Decree No. 1684 dated 30 November, 2024 of the Government of the Russian Federation with amendments of 03.08.2026
GOVERNMENT OF THE RUSSIAN FEDERATION
RESOLUTION
dated November 30, 2024 No. 1684
ON APPROVAL OF THE RULES FOR STATE REGISTRATION OF MEDICAL DEVICES
(as amended by Resolutions of the Government of the Russian Federation dated August 13, 2025 No. 1206, October 27, 2025 No. 1670, December 30, 2025 No. 2214, August 3, 2026 No. 974)
The Government of the Russian Federation resolves:
Paragraph 1 is effective until December 31, 2028 (second paragraph of paragraph 7).
1. To approve the attached Rules for State Registration of Medical Devices.
Paragraph 2 is effective until December 31, 2028 (second paragraph of paragraph 7).
2. State registration of medical devices, including state registration of medical devices with a low degree of potential risk of their use, for which specific features of state registration have been established, amendments to documents contained in registration dossiers for medical devices, applications for which were submitted to the Federal Service for Surveillance in Healthcare prior to the date of entry into force of this Resolution, shall be carried out in accordance with the requirements of the rules for state registration of medical devices that were in effect prior to the date of entry into force of this Resolution.
Registration certificates issued for medical devices that have undergone state registration on the basis of an application submitted to the Federal Service for Surveillance in Healthcare prior to the date of entry into force of the Rules approved by this Resolution shall remain valid until amendments are made to the information contained in the registry entry of the State Register of Medical Devices and Organizations (Individual Entrepreneurs) Engaged in the Manufacture and Production of Medical Devices.
3. Medical organizations meeting the requirements for medical organizations conducting clinical trials of medical devices, approved in accordance with the established procedure, and having confirmed such compliance prior to March 1, 2025, shall notify the Federal Service for Surveillance in Healthcare by sending a letter to the address of the said Service (in hard copy, either delivered directly or sent by registered mail with acknowledgment of receipt, or in the form of an electronic document signed with an enhanced qualified electronic signature or an enhanced unqualified electronic signature, the certificate of the verification key of which was created and is used within the infrastructure ensuring information and technological interaction of information systems used for the provision of state and municipal services in electronic form, in accordance with the procedure established by the Government of the Russian Federation, to the email address of the Federal Service for Surveillance in Healthcare) by September 1, 2025, regarding compliance with the requirements established by subparagraph “e” of paragraph 6 and/or subparagraph “d” of paragraph 7 of the Rules approved by this Resolution.
4. To declare invalid the acts of the Government of the Russian Federation according to the list set forth in the Annex.
5. To approve the attached amendments to be made to the acts of the Government of the Russian Federation.
Paragraph 6 is effective until December 31, 2028 (second paragraph of paragraph 7).
6. The exercise of the powers provided for by this Resolution shall be carried out by the Federal Service for Surveillance in Healthcare within the limits of the maximum number of its employees established by the Government of the Russian Federation, as well as the budgetary allocations provided to the Federal Service for Surveillance in Healthcare for administration and management in the area of its established functions.
7. This Resolution shall enter into force on March 1, 2025, with the exception of subparagraph “e” of paragraph 137 of the Rules approved by this Resolution, which shall enter into force on September 1, 2027. (as amended by Resolutions of the Government of the Russian Federation dated August 13, 2025 No. 1206 and August 3, 2026 No. 974)
Paragraphs 1, 2 and 6 of this Resolution and the Rules approved by this Resolution shall remain in effect until December 31, 2028, with the exception of paragraphs 63, 87 and 101 of the said Rules, which shall remain in effect until December 31, 2025.
(as amended by Resolution of the Government of the Russian Federation dated December 30, 2025 No. 2214)
Chairman of the Government
of the Russian Federation
M. MISHUSTIN
APPROVED
by Resolution of the Government
of the Russian Federation
dated November 30, 2024 No. 1684
The Rules are effective until December 31, 2028 (second paragraph of paragraph 7).
RULES FOR STATE REGISTRATION OF MEDICAL DEVICES
(as amended by Resolutions of the Government of the Russian Federation [dated August 13, 2025 No. 1206], [dated August 3, 2026 No. 974])
I. General Provisions
1. These Rules establish the procedure for state registration of medical devices subject to circulation in the territory of the Russian Federation (hereinafter referred to as medical devices).
2. Any instruments, apparatuses, devices, equipment, materials and other products used for medical purposes separately or in combination with each other, as well as together with other accessories necessary for the use of the said products for their intended purpose, including special software, and intended by the manufacturer (producer) for the prevention, diagnosis, treatment and medical rehabilitation of diseases, monitoring of the condition of the human body, conducting medical research, restoration, replacement, modification of the anatomical structure or physiological functions of the body, prevention or termination of pregnancy, the functional purpose of which is not achieved through pharmacological, immunological, genetic or metabolic effects on the human body, shall be subject to state registration.
Medical devices specified in Part 5 of Article 38 of the Federal Law “On the Fundamentals of Health Protection of Citizens in the Russian Federation” shall not be registered in the territory of the Russian Federation.
3. State registration of medical devices shall be carried out by the Federal Service for Surveillance in Healthcare (hereinafter referred to as the registration authority).
4. The following basic concepts are used in these Rules:
“safety of medical devices” — absence of an unacceptable risk associated with causing harm to life, human health and the environment;
“manufacturer’s (producer’s) evidentiary materials for a medical device” — evidentiary materials (documents) of the manufacturer (producer) of the medical device or another organization containing the results of tests for the purpose of determining the quality and safety of the medical device, compliance of its characteristics (properties) with the requirements of regulatory documentation, technical and operational documentation of the manufacturer (producer) and/or studies for the purpose of assessing the biological safety of the medical device, as well as substantiation of the selected methods and their validity, allowing assessment of the methods (procedures) applied and the list of testing equipment used;
“applicant” — the manufacturer (producer) of the medical device or the authorized representative of the manufacturer (producer);
“unified applicant’s personal account” — a subsystem of the unified applicant’s personal account in the federal state information system “Unified Portal of State and Municipal Services (Functions)”;
“unified medical organization’s personal account” — a subsystem of the unified medical organization’s personal account in the federal state information system “Unified Portal of State and Municipal Services (Functions)”;
“quality of a medical device” — the totality of properties and characteristics of a medical device affecting its ability to act for its intended purpose provided that it complies with the requirements of regulatory documentation, technical and operational documentation of the manufacturer (producer). The intended purpose of a medical device means the decision of the manufacturer (producer) regarding the intended use of the medical device, based on its specific properties ensuring the achievement of the objectives of medical use and reflected in the technical and operational documentation of the manufacturer (producer);
“clinical trials” — a designed and planned systematic study undertaken, including with the participation of a human being as a subject, to assess the safety and effectiveness of a medical device;
“model (brand) of a medical device” — a version of a medical device characterized by certain design and technological solutions and specific values of indicators of its intended (functional) purpose;
“regulatory documentation” — a document regulating safety and quality requirements, as well as the intended effectiveness of the envisaged use and methods for monitoring compliance of the medical device with these requirements. The composition of information specified in the regulatory documentation shall be approved by the registration authority;
“accessory” — a product that is not a medical device, determined by its manufacturer for joint use with one or more medical devices when used in accordance with their intended purpose;
“manufacturer (producer) of a medical device” — a legal entity or an individual registered as an individual entrepreneur, responsible for the development and manufacture of a medical device, making it available for use in its own name regardless of whether the medical device was developed and/or manufactured by this person or on its behalf by another person (persons), and bearing responsibility for the safety, quality and effectiveness of the medical device;
“production site” — a geographically separate complex intended for carrying out the entire production process of a medical device or certain stages thereof.
The following shall be understood as certain stages of the production process:
manufacture of the entire medical device or its main units, except for main units that are medical devices registered in accordance with the established procedure in the territory of the Russian Federation, in geographically separate complexes included in the organizational structure of the manufacturer (producer) of the medical device;
manufacture under contracts with a third-party manufacturer (contractor) of the entire medical device or its main units, except for main units that are medical devices registered in accordance with the established procedure in the territory of the Russian Federation;
sterilization of a medical device (for medical devices supplied in sterile form);
labeling of a medical device (when labeling is carried out by the manufacturer (producer) of the medical device).
Main units shall mean products, except for spare parts of a medical device, released into circulation in the name of the manufacturer (producer) of the medical device being registered, not mechanically connected with other main units of the medical device upon delivery of the medical device and ensuring the functioning of the medical device in accordance with its intended purpose.
A building, structure or premises designated as “residential” may not constitute a production site for medical devices;
“registration dossier” — a set of documents submitted by the applicant for state registration of a medical device, making amendments to such documents, cancellation of state registration of a medical device, as well as copies of decisions made by the registration authority and the federal state budgetary institution subordinate to the registration authority (hereinafter referred to as the expert institution) with regard to a specific medical device;
“registration number of a medical device” — a code designation assigned to a medical device upon its state registration, under which it is entered into the state register of medical devices and organizations (individual entrepreneurs) engaged in the manufacture and production of medical devices (hereinafter referred to as the state register), and retained unchanged during the circulation of the medical device;
“technical documentation of the manufacturer (producer) of a medical device” — a document (documents) regulating the design of a medical device, establishing technical requirements and containing data for its development, production, application, operation, maintenance, repair, disposal or destruction;
“technical tests of a medical device” — tests for the purpose of determining the quality and safety of a medical device, compliance of its characteristics (properties) with the requirements of regulatory documentation, technical and operational documentation of the manufacturer (producer), and making a subsequent decision on the possibility of conducting clinical trials, carried out in a testing laboratory (center) accredited in the national accreditation system, taking into account the scope of its accreditation;
“toxicological studies of a medical device” — studies for the purpose of assessing the biological safety of a medical device and making a subsequent decision on the possibility of conducting clinical trials, carried out in a testing laboratory (center) accredited in the national accreditation system, taking into account the scope of its accreditation;
“authorized representative of the manufacturer (producer) of a medical device” — a legal entity or an individual registered as an individual entrepreneur, being residents of the Russian Federation, authorized by the manufacturer (producer) of the medical device to represent its interests regarding the circulation of the medical device in the territory of the Russian Federation, including regarding conformity assessment procedures and state registration;
“operational documentation of the manufacturer (producer) of a medical device” — a document (documents) intended to familiarize the consumer with the design of the medical device, regulating the conditions and rules of operation (use for the intended purpose, maintenance, routine repair, storage and transportation), guaranteed values of the main parameters and characteristics (properties) of the medical device established by the manufacturer (producer), warranty obligations, as well as information on its disposal or destruction;
“electronic applicant’s account” — a service in the automated information system of the registration authority in the information and telecommunications network “Internet” (hereinafter referred to as the “Internet” network), allowing the applicant, after undergoing identification and authentication procedures, to interact with the registration authority, as well as to obtain access to information and documents contained in the registration dossier, in cases provided for by these Rules;
“electronic image of a document” — a document on a paper medium converted into electronic form by scanning while preserving its details;
“effectiveness of a medical device” — the ability of a medical device to comply with the intended purpose established by the manufacturer (producer). The effectiveness of a medical device is confirmed by the practice of clinical use, including clinical trials.
5. State registration of medical devices, confirmation of the effectiveness of which requires conducting clinical trials involving humans and obtaining permission from the registration authority to conduct clinical trials, shall be carried out in accordance with paragraphs 63–86 of these Rules.
State registration of medical devices, confirmation of the effectiveness of which does not require conducting clinical trials involving humans or obtaining permission from the registration authority to conduct such clinical trials, shall be carried out in accordance with paragraphs 87–100 of these Rules.
Amendments to documents contained in the registration dossier shall be made in accordance with paragraphs 112–118 of these Rules with regard to amendments not requiring an examination of the quality, effectiveness and safety of the medical device, and in accordance with paragraphs 120–133 of these Rules with regard to amendments requiring an examination of the quality, effectiveness and safety of the medical device.
Amendments to documents contained in the registration dossier for software using artificial intelligence technologies that is a medical device shall be made in accordance with paragraphs 112–118, or 120–133, or 135 and 136 of these Rules.
State registration of medical devices shall be carried out on the basis of the results of technical tests, toxicological studies, clinical trials, which constitute forms of conformity assessment of medical devices taking into account classification depending on the potential risk of their use, inspection of production, analysis of the manufacturer’s (producer’s) evidentiary materials for the medical device, examination of the quality, effectiveness and safety of medical devices taking into account classification depending on the potential risk of their use, as well as tests for the purpose of type approval of measuring instruments (with regard to medical devices classified as measuring instruments in the sphere of state regulation of ensuring the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation).
6. Clinical trials of medical devices (except for in vitro diagnostic medical devices) shall be conducted in medical organizations meeting the following requirements:
a) availability of a license to carry out medical activities indicating the list of works (services) constituting medical activities, based on the intended purpose and area of application of the medical devices in respect of which the trials are conducted;
b) availability in the charter of the medical organization of the following types of activities:
scientific (research) activities;
conducting clinical trials of medical devices;
c) availability of an intensive care and resuscitation department (ward) (in the event of conducting clinical trials of medical devices involving a human being as a subject, classified as classes 2b and 3 depending on the potential risk of use);
d) ensuring the protection of confidential information;
e) availability of standard operating procedures regulating the conduct of clinical trials of medical devices, covering, among other things:
qualification requirements and training of personnel;
interaction with the ethics committee;
obtaining informed consent;
the procedure for conducting clinical trials;
maintenance and accounting of clinical trial documentation;
procedures related to the creation and verification of a dataset for conducting clinical trials of software using artificial intelligence technologies that is a medical device (in the event of conducting such trials);
f) ensuring the entry of information on the trials conducted, including information on the issued act of assessment of the results of clinical trials, into the automated information system of the registration authority in the procedure established by the registration authority;
g) specialists of the medical organization directly conducting procedures related to clinical trials or making decisions related to clinical trials shall have higher medical education in a specialty corresponding to the area of medical application of the medical device.
7. Medical organizations conducting clinical trials of in vitro diagnostic medical devices shall meet the following requirements:
a) availability of a license to carry out medical activities in laboratory diagnostics and clinical laboratory diagnostics;
b) availability in the charter of the medical organization of the following types of activities:
scientific (research) activities;
conducting clinical trials of medical devices;
c) ensuring the protection of confidential information;
d) availability of standard operating procedures regulating the conduct of clinical trials of medical devices, covering, among other things:
qualification requirements and personnel training;
the procedure for verification and calibration of equipment;
the procedure for conducting clinical trials;
maintenance and accounting of clinical trial documentation;
e) ensuring the entry of information on the clinical trials conducted, including information on the issued act of assessment of the results of clinical trials of an in vitro diagnostic medical device, into the automated information system of the registration authority in the procedure established by the registration authority;
f) specialists of the medical organization directly conducting procedures related to clinical trials or making decisions related to clinical trials shall have higher medical education or secondary vocational medical education in a specialty corresponding to the area of medical application of the medical device.
8. Establishment of compliance of a medical organization with the requirements of paragraphs 6 and/or 7 of these Rules shall be carried out by the registration authority for the purpose of recognizing the competence of the medical organization in conducting clinical trials of medical devices according to the relevant profile of medical care provided by the medical organization.
The registration authority shall maintain a list of medical organizations conducting clinical trials and shall publish it on its official website on the “Internet” network.
9. A medical organization planning to conduct clinical trials of medical devices shall submit to the registration authority, using the federal state information system “Unified Portal of State and Municipal Services (Functions),” an application of intent to conduct clinical trials of medical devices and the documents specified in paragraph 11 of these Rules, in the form of electronic documents or electronic images of documents signed with an enhanced qualified electronic signature or an enhanced unqualified electronic signature, the certificate of the verification key of which was created and is used within the infrastructure ensuring information and technological interaction of information systems used for the provision of state and municipal services in electronic form, in accordance with the procedure established by the Government of the Russian Federation (hereinafter referred to as the application for conducting clinical trials).
10. The following information shall be specified in the application for conducting clinical trials:
a) full and abbreviated (if available) names, including the corporate name, organizational and legal form of the medical organization, address of its location, as well as telephone numbers and email addresses of the medical organization (if available);
b) details of the license for medical activities;
c) taxpayer identification number;
d) list of works (services) in accordance with the license to carry out medical activities;
e) information on the availability (absence) of accreditation in the national accreditation system as a testing laboratory (center) and/or medical laboratory (for medical organizations conducting clinical trials of in vitro diagnostic medical devices);
f) information on the sanitary and epidemiological conclusion (indicating the number and date) on the compliance with sanitary rules of the premises necessary for performing works (services) in carrying out medical activities in anesthesiology and resuscitation (except for medical organizations conducting clinical trials of in vitro diagnostic medical devices);
g) information on the sanitary and epidemiological conclusion (indicating the number and date) on the compliance with sanitary rules of the premises necessary for performing works (services) in carrying out medical activities in laboratory diagnostics, clinical laboratory diagnostics (for medical organizations conducting clinical trials of in vitro diagnostic medical devices);
h) information on the sanitary and epidemiological conclusion on the compliance of the conditions for performing work with biological substances, biological and microbiological organisms and their toxins with sanitary rules (for medical organizations conducting clinical trials of in vitro diagnostic medical devices);
i) details of documents confirming compliance of the specialists of the medical organization directly conducting procedures related to clinical trials or making decisions related to clinical trials with the requirements of subparagraph “g” of paragraph 6 and/or subparagraph “f” of paragraph 7 of these Rules, indicating the surnames, first names and patronymics (if available) of the specialists, dates of birth, level of education, name of specialty, series and number of the education document, its date, as well as the insurance number of the individual personal account.
11. For the purpose of establishing compliance of medical organizations with the requirements imposed on medical organizations conducting clinical trials of medical devices, the medical organization shall submit the following documents, certified by the medical organization in accordance with the established procedure:
a) copies of documents confirming the availability of an intensive care and resuscitation department (ward) (in the event of conducting clinical trials of medical devices involving a human being as a subject, classified as classes 2b and 3 depending on the potential risk of use);
b) a copy of the document approved by the head of the medical organization establishing the bed capacity, structure and staffing table of the medical organization;
c) copies of documents confirming the availability of a clinical diagnostic (diagnostic) laboratory, indicating its profile (for medical organizations conducting clinical trials of in vitro diagnostic medical devices);
d) a copy of the document approved by the head of the medical organization establishing the procedure for handling confidential information;
e) copies of standard operating procedures regulating the conduct of clinical trials of medical devices;
f) a copy of the document approved by the head of the medical organization establishing the procedure for transferring information on clinical trials conducted, including information on the issued act of assessment of the results of clinical trials, to the automated information system of the Federal Service for Surveillance in Healthcare;
g) copies of documents confirming compliance of the specialists of the medical organization directly conducting procedures related to clinical trials or making decisions related to clinical trials with the requirements of subparagraph “g” of paragraph 6 and/or subparagraph “f” of paragraph 7 of these Rules (submitted if the documents were obtained by the specialists before 1992, or were issued to the specialists by educational organizations forming part of the law enforcement structures or military departments of the Russian Federation, or were obtained by the specialists abroad).
12. A medical organization shall have the right to submit, on its own initiative, the documents, information on which is specified in the application for conducting clinical trials in accordance with paragraph 10 of these Rules.
The registration authority shall not have the right to require submission of documents and information that are at the disposal of bodies providing state services, bodies providing municipal services, other state bodies, local self-government bodies, or organizations subordinate to state bodies or local self-government bodies participating in the provision of state and municipal services.
The registration authority shall not have the right to require the medical organization to submit documents not provided for by paragraph 11 of these Rules.
13. The documents specified in paragraph 11 of these Rules shall be produced in multicolor format with a resolution of at least 300 dots per inch in *.pdf format with a text layer allowing the selection and copying of blocks, as well as searching.
The size of any of the files of the documents specified in this paragraph shall not exceed 100 MB.
The application for conducting clinical trials and the documents submitted by the medical organization in accordance with paragraph 11 of these Rules shall be accepted and registered by the registration authority on the day of their receipt.
14. The registration authority, within a period not exceeding 20 working days from the date of receipt of the application for conducting clinical trials and the documents submitted by the medical organization in accordance with paragraph 11 of these Rules, shall examine them, verify the completeness and reliability of the information contained therein, and verify the compliance of the medical organization with the requirements for medical organizations conducting clinical trials of medical devices established by paragraphs 6 and/or 7 of these Rules.
Verification of the constituent documents and the availability of a license with the medical organization to carry out medical activities in accordance with the area of medical application of medical devices shall be carried out by the registration authority using the unified system of interdepartmental electronic interaction and regional systems of interdepartmental electronic interaction connected thereto, or upon an interdepartmental request of the registration authority.
15. The registration authority, within the period provided for by paragraph 14 of these Rules, shall make a decision on the compliance or non-compliance of the medical organization with the requirements for medical organizations conducting clinical trials of medical devices established by paragraphs 6 and/or 7 of these Rules, which shall be formalized by the relevant decision.
16. In the event of a decision on the compliance of the medical organization with the requirements established by paragraphs 6 and/or 7 of these Rules, the registration authority, on the day of making the said decision, shall enter information about the medical organization into the list of medical organizations conducting clinical trials of medical devices and shall notify the medical organization of its inclusion in the list of medical organizations conducting clinical trials of medical devices by placing the relevant notification in the unified medical organization’s personal account.
17. The list of medical organizations conducting clinical trials of medical devices shall contain the following information:
a) date of inclusion in the list of medical organizations conducting clinical trials of medical devices;
b) full name, organizational and legal form of the medical organization;
c) address of the location of the medical organization;
d) contact telephone number, fax (if available);
e) email address (if available);
f) list of works (services) in accordance with the license to carry out medical activities.
18. In the event of a decision on the non-compliance of the medical organization with the requirements established by paragraphs 6 and/or 7 of these Rules, the registration authority, on the day of making the said decision, shall notify the medical organization by placing the relevant notification with a reasoned justification for the decision made in the unified medical organization’s personal account.
19. Exclusion from the list of medical organizations conducting clinical trials of medical devices shall be carried out by the registration authority in the following cases:
a) submission of an application for exclusion from the list of medical organizations conducting clinical trials of medical devices in the form of an electronic document signed with an enhanced qualified electronic signature or an enhanced unqualified electronic signature, through the unified medical organization’s personal account;
b) detection by the registration authority of violations of mandatory requirements during the conduct by the medical organization of clinical trials of medical devices based on the results of state control over the circulation of medical devices;
c) submission by the medical organization of unreliable information when submitting the application for conducting clinical trials and the documents submitted in accordance with paragraph 11 of these Rules, as well as when preparing acts of clinical trials of medical devices;
d) liquidation of the medical organization or termination of the license to carry out medical activities;
e) untimely submission or failure to submit the information and documents provided for by paragraph 20 of these Rules;
f) failure to notify the registration authority by September 1, 2025, of compliance with the requirements established by subparagraph “e” of paragraph 6 and/or subparagraph “d” of paragraph 7 of these Rules.
20. In the event of a change in the information contained in the list of medical organizations conducting clinical trials of medical devices, a medical organization included in the list of medical organizations conducting clinical trials of medical devices shall, within 30 calendar days from the date of such change, submit to the registration authority, using the unified medical organization’s personal account, an application for making amendments to the said information, as well as documents confirming such changes, in the form of electronic documents or electronic images of documents signed with an enhanced qualified electronic signature or an enhanced unqualified electronic signature.
The registration authority shall, within 20 working days from the date of submission by the medical organization of the application for making amendments to the information contained in the list of medical organizations conducting clinical trials of medical devices:
examine the submitted application and documents;
notify the medical organization of the decision made in writing by placing it in the form of an electronic document signed with an enhanced qualified electronic signature of an authorized official in the unified medical organization’s personal account.
21. In the event of exclusion from the list of medical organizations conducting clinical trials of medical devices (except for the case provided for in subparagraph “a” of paragraph 19 of these Rules), a medical organization shall have the right to re-apply to the registration authority with an application for conducting clinical trials after eliminating the comments that served as the reason for the exclusion, but not earlier than 3 years from the date of exclusion from the said list.
In the event that the registration authority identifies violations again during the conduct of clinical trials of medical devices by a medical organization, the medical organization shall be excluded from the list of medical organizations conducting clinical trials of medical devices, without the right to re-submit an application for conducting clinical trials.
22. Medical organizations conducting clinical trials of medical devices shall enter information on the trials conducted into the automated information system of the registration authority within a period not exceeding 3 working days from the date of their completion.
23. The register of issued permits for conducting clinical trials of medical devices shall be posted by the registration authority, in the manner established by it, on its official website on the «Internet».
24. The specific features of state registration of domestically manufactured medical devices (medical devices in whose application for state registration (hereinafter referred to as the registration application) a legal entity or an individual registered as an individual entrepreneur, being residents of the Russian Federation, is indicated as the manufacturer (producer), and which also have a production site in the territory of the Russian Federation), provided that technical tests and toxicological studies of the medical device are conducted, as well as tests of the medical device for the purpose of type approval of measuring instruments (with regard to medical devices classified as measuring instruments in the sphere of state regulation of ensuring the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation) at the Federal State Budgetary Institution “All-Russian Research and Testing Institute of Medical Equipment” of the Federal Service for Surveillance in Healthcare (hereinafter referred to as the institution), clinical trials — at medical organizations meeting the requirements established by paragraphs 6 and 7 of these Rules and included in the network of national medical research centers, the composition of which is approved by the Ministry of Health of the Russian Federation, as well as software using artificial intelligence technologies intended for processing medical images obtained during radiological examinations, including computed tomography, radiography, fluorography and mammography, provided that clinical trials are conducted at the State Budgetary Healthcare Institution of the City of Moscow “Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies” of the Moscow Department of Health (hereinafter respectively referred to as the clinical center and domestically manufactured medical devices), are provided for by paragraphs 101–109 of these Rules.
State registration of domestically manufactured medical devices shall be carried out in accordance with paragraphs 63–86 or 87–100 of these Rules or in accordance with the specific features of state registration of domestically manufactured medical devices established by paragraphs 101–109 of these Rules, at the applicant’s choice.
25. The fact of state registration of a medical device in accordance with these Rules shall be confirmed by a registry entry made by the registration authority in the state register (hereinafter referred to as the registry entry).
State registration of a medical device in accordance with these Rules shall be indefinite.
26. The inclusion of several models (brands) of a medical device in one registry entry, including models (brands) belonging to different types of medical devices in accordance with the nomenclature classification of medical devices by type approved by the Ministry of Health of the Russian Federation (hereinafter referred to as the nomenclature classification of medical devices by type), shall be possible provided that these models (brands) meet all of the following criteria:
a) the models (brands) of the medical device are manufactured by one manufacturer (producer) according to one set of the manufacturer’s (producer’s) technical documentation;
b) the models (brands) of the medical device belong to the same class of potential risk of use;
c) the models (brands) of the medical device have the same functional purpose and operating principle;
d) the models (brands) of the medical device are intended to determine the presence and/or quantitative content in a biological sample of the same clinically (diagnostically) significant analyte(s) (for in vitro diagnostic medical devices);
e) the models (brands) of the medical device have different configurations that do not affect the operating principle and functional purpose, which makes it possible to expand or specialize their use for medical purposes (where applicable);
f) the models (brands) of the medical device have different technical parameters that do not affect the operating principle and functional purpose (where applicable);
g) the models (brands) of the medical device form a size (model) range or constitute a group of versions of the medical device. At the same time, a group of versions of a medical device means products for which one group drawing of parts and/or one set of the manufacturer’s (producer’s) technical documentation for the medical device has been prepared;
h) the models (brands) of the medical device have the same characteristics in terms of:
field of application;
invasiveness;
sterility (including taking into account sterilization methods);
frequency of use (single use, repeated use by one patient, repeated use by several patients);
operational and structural features.
27. The state duty for actions performed by the registration authority in carrying out state registration of medical devices shall be paid in accordance with the legislation of the Russian Federation on taxes and fees.
The registration authority shall obtain information on the payment of the state duty through access to the State Information System on State and Municipal Payments provided for by Article 21.3 of the Federal Law “On the Organization of the Provision of State and Municipal Services”.
28. The registration authority shall post information related to the state registration of a medical device, amendments to the documents contained in the registration dossier, and cancellation of state registration on its official website on the Internet, in the applicant’s unified personal account and the applicant’s electronic account.
29. For the purpose of undergoing the state registration procedure for a medical device, a foreign manufacturer (producer) of a medical device shall appoint an authorized representative of the manufacturer (producer) acting during the period of circulation of the medical device in the territory of the Russian Federation and maintain up-to-date information about such representative of the If information about the authorized representative of the manufacturer (producer) is not specified in the documents contained in the registration dossier or is not up to date, the foreign manufacturer (producer) shall, before September 1, 2027, appoint an authorized representative of the manufacturer (producer) acting during the period of circulation of the medical device in the territory of the Russian Federation or update the information about such representative. (as amended by Resolutions of the Government of the Russian Federation No. 1206 dated August 13, 2025, and No. 974 dated August 3, 2026)
30. Prior to submitting to the registration authority an application for registration of a medical device or for amendments to the documents contained in the registration dossier in accordance with paragraphs 63, 87, 112, 120 and 135 of these Rules, or submitting to the institution an application for examination of the quality, effectiveness and safety of a domestically manufactured medical device in accordance with paragraph 101 of these Rules, the applicant shall collect evidence of the safety and effectiveness of the medical device and prepare the relevant registration dossier documents.
31. For the purpose of preparing the documents contained in the registration dossier for their subsequent submission to the registration authority or the institution, the applicant (as applicable depending on the procedure):
a) shall ensure the conduct of technical tests and/or include in the set of documents the available data (evidentiary materials of the manufacturer (producer) of the medical device);
b) shall ensure the conduct of toxicological studies of the medical device and/or accessories to the medical device that directly or indirectly come into contact with the surface of the human body, its mucous membranes, internal body environments, for which such interaction (contact) is necessary to perform their intended functions, and/or include in the set of documents the available data (evidentiary materials of the manufacturer (producer) of the medical device);
c) shall ensure the conduct of clinical trials of the medical device (except for state registration of medical devices, confirmation of the effectiveness of which requires clinical trials involving humans and obtaining a permit from the registration authority, carried out in accordance with paragraphs 63–86 of these Rules).
Clinical trials for the purpose of state registration of a medical device, confirmation of the effectiveness of which requires clinical trials involving humans (except for domestically manufactured medical devices, in vitro diagnostic medical devices, medical devices that have undergone state registration in accordance with the specific features established by the Government of the Russian Federation, and software that is a medical device), shall be conducted on the basis of a permit for conducting clinical trials issued by the registration authority, as well as an opinion on the ethical justification for conducting clinical trials issued by the Ethics Council in the Sphere of Circulation of Medical Devices of the Ministry of Health of the Russian Federation (hereinafter referred to as the Ethics Council), in cases established by these Rules.
Clinical trials involving humans for the purpose of state registration of a domestically manufactured medical device shall be conducted on the basis of an opinion on the ethical justification for conducting clinical trials issued by the Ethics Council, in cases established by these Rules. A permit for conducting clinical trials involving humans issued by the registration authority is not required for domestically manufactured medical devices whose state registration procedure will be carried out in accordance with paragraphs 101–109 of these Rules.
For in vitro diagnostic medical devices, medical devices that have undergone state registration in accordance with the specific features established by the Government of the Russian Federation, and software that is a medical device, obtaining a permit from the registration authority to conduct clinical trials, including those involving humans, is not required;
d) shall ensure the conduct of tests for the purpose of type approval of measuring instruments (with regard to medical devices classified as measuring instruments in the sphere of state regulation of ensuring the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation);
e) shall ensure the conduct of inspection of the production of medical devices for compliance with the requirements for the implementation, maintenance and assessment of the quality management system for medical devices depending on the potential risk of their use, approved by the Government of the Russian Federation (hereinafter referred to as the requirements for the implementation, maintenance and assessment of the quality management system for medical devices). The initial inspection of the production of medical devices for compliance with the requirements for the implementation, maintenance and assessment of the quality management system for medical devices, carried out for the purpose of submitting its results to the registration authority or the institution within the procedures provided for by Sections II–VI of these Rules, shall be conducted by the institution or an expert institution.
32. The Ethics Council is a permanent body established by the Ministry of Health of the Russian Federation to conduct an examination of the ethical justification for conducting clinical trials of medical devices involving humans as subjects (hereinafter referred to as ethical examination).
33. The main tasks of the Ethics Council are:
a) conducting an ethical examination of documents related to the conduct of clinical trials of medical devices;
b) issuing an opinion on the ethical justification of the possibility or impossibility of conducting clinical trials of medical devices involving humans as subjects.
34. The Ethics Council, in accordance with the tasks assigned to it, shall have the right to:
a) receive documents necessary for conducting the ethical examination;
b) request from the applicant any missing materials necessary for conducting the ethical examination.
35. The composition of the Ethics Council shall be approved by the Ministry of Health of the Russian Federation and formed from representatives of medical and scientific organizations, educational institutions of higher education, as well as representatives of public organizations, religious organizations and mass media (hereinafter referred to as council experts).
The number of representatives of medical organizations may not exceed half of the total number of council experts.
36. The composition of the Ethics Council shall be reviewed as necessary, but not more than once a year.
Changes and additions to the composition of the Ethics Council shall be approved by an order of the Ministry of Health of the Russian Federation.
37. The Ethics Council shall consist of a chairperson, deputy chairpersons and members of the Ethics Council.
38. The chairperson of the Ethics Council shall be appointed by the Minister of Health of the Russian Federation from among council experts who have higher medical education, an academic degree of Candidate of Medical Sciences or Doctor of Medical Sciences, and experience in conducting clinical trials of medical devices and resolving issues related to the ethical aspects of clinical trials of medical devices.
39. The chairperson of the Ethics Council shall exercise general management, determine the areas of work of the Ethics Council, organize its work, distribute duties among the experts, and supervise the conduct of ethical examinations.
In the absence of the chairperson of the Ethics Council, his or her duties shall be performed by one of the deputy chairpersons who has higher medical education.
40. Council experts shall not be dependent in any way on manufacturers (producers) of medical devices or other persons interested in the results of the ethical examination.
41. Expert groups may be established within the Ethics Council.
42. The following requirements shall apply to council experts:
a) for persons with higher medical education:
postgraduate and/or additional professional education, a specialist certificate;
experience in conducting clinical trials of medical devices and resolving issues related to the ethical aspects of clinical trials of medical devices;
b) for other persons:
higher education;
experience and knowledge in the field of ethical and legal aspects of protecting the rights and freedoms of individuals and citizens.
43. Meetings of the Ethics Council shall be conducted by the chairperson or, on his/her instructions, by a deputy chairperson and shall be documented by minutes signed by the chairperson of the Ethics Council or his/her deputy.
Materials for the next meeting of the Ethics Council shall be sent to the Ethics Council experts by the department of the Ministry of Health of the Russian Federation responsible for the organizational and technical support of the Ethics Council (hereinafter referred to as the department) no later than 3 working days before the date of the meeting set by the department.
44. A meeting of the Ethics Council shall be considered duly constituted if at least two thirds of its members are present.
Council experts shall participate in its work personally; delegation of powers is not permitted.
Council experts participating in the planned clinical trial of a medical device shall not be involved in the ethical examination.
45. Council experts participating in the planned clinical trial of a medical device shall not be involved in the ethical examination.
46. The decision of the Ethics Council shall be adopted by open voting by a simple majority of the votes of the experts present at the meeting.
In the event of a tie, the decision for which the chairperson presiding at the meeting voted shall be deemed adopted.
47. Based on the results of the meeting of the Ethics Council, an opinion on the ethical justification for conducting clinical trials of the medical device shall be prepared in the form set out in the appendix, signed by the chairperson of the Ethics Council or his/her deputy. One copy of the opinion shall be handed to the applicant or sent to the applicant by registered mail with acknowledgment of receipt, and the second copy shall be kept by the department.
48. An expert of the council who disagrees with the decision adopted shall have the right to state his/her dissenting opinion in writing, which shall be attached to the relevant opinion of the Ethics Council provided for in paragraph 47 of these Rules and shall constitute an integral part thereof.
49. Information on the composition of the Ethics Council and its work plans shall be posted in the relevant section of the website of the Ministry of Health of the Russian Federation on the Internet and kept up to date.
Information on the current activities of the Ethics Council shall be posted in the relevant section of the website of the Ministry of Health of the Russian Federation within 3 working days from the date of the meeting.
50. At the applicant’s request, prior to the commencement of the state registration procedure, the expert institution shall provide consultation, including on procedures related to the state registration of medical devices, including preliminary analysis and assessment of the registration dossier, in the manner established by the registration authority.
Consultation is not mandatory for obtaining the state service of state registration of medical devices.
In order to comply with the principles of independence and impartiality when conducting an examination of the quality, effectiveness and safety of a medical device, as well as to eliminate the possibility of a conflict of interest, officials of the expert institution who provided consultation or conducted an inspection of the production of medical devices for compliance with the requirements for the implementation, maintenance and assessment of the quality management system for medical devices may not conduct an examination of the quality, effectiveness and safety of the medical device in respect of which the consultation was provided.
51. In respect of a medical device, the applicant may submit only one of the applications provided for by paragraph 63, paragraph 87, subparagraph “a” of paragraph 101, subparagraph “a” of paragraph 112, subparagraph “a” of paragraph 120, or paragraph 135 of these Rules. If, during the period of review of the registration dossier by the registration authority or the institution in accordance with the procedure provided for by these Rules (prior to the final decision provided for by this procedure), a repeated and/or new application from among those specified in the first sentence of this paragraph in respect of the medical device is submitted or sent to the registration authority or the institution, such application shall not be accepted by the registration authority or the institution.
52. The registration authority shall form the registration dossier from the following documents (as applicable):
a) the registration application and the documents provided for by paragraph 65, 87 or 101 of these Rules, the application for renewal of state registration of a medical device and the documents provided for by paragraph 80 of these Rules, requests and documents provided for by paragraph 74 or 96 of these Rules, the application for amendments to the documents contained in the registration dossier and the documents provided for by paragraphs 112 and/or 120 of these Rules, as well as the application for cancellation of state registration of a medical device and the documents provided for by subparagraph “b” of paragraph 139 of these Rules;
b) a copy of the assignment for conducting an examination of the quality, effectiveness and safety of the medical device, prepared by the registration authority;
c) opinions prepared by the expert institution when conducting an examination of the quality, effectiveness and safety of the medical device;
d) the applicant’s objections to the opinion of the expert institution on the results of the examination of the quality, effectiveness and safety of the medical device, and decisions of the registration authority following consideration of the applicant’s objections to the opinion;
e) copies of orders of the registration authority;
f) copies of notifications sent by the registration authority;
g) copies of reports on the inspection of the production of the medical device.
53. Documents contained in the registration dossier shall be submitted to the registration authority using the applicant’s unified personal account in the form of electronic documents or electronic images of documents signed with an enhanced qualified electronic signature or an enhanced unqualified electronic signature of the applicant.
Paper documents contained in the registration dossier, electronic images of which are submitted by the applicant, shall be certified in accordance with the established procedure.
54. Documents contained in the registration dossier shall be prepared in full-color format with a resolution of at least 300 dots per inch in *.pdf format with a text layer allowing blocks to be selected and copied, as well as searches to be performed.
The size of any registration dossier file shall not exceed 100 MB.
The date of issuance shall be indicated in each document contained in the registration dossier.
55. If the documents contained in the registration dossier are drawn up in a foreign language, they shall be submitted with a translation into Russian certified in accordance with the established procedure.
56. The manufacturer’s (producer’s) technical documentation for the medical device and the manufacturer’s (producer’s) operational documentation for the medical device, including the instructions for use or operating manual of the medical device, may additionally be submitted through the applicant’s unified personal account in the form of information signed with an enhanced qualified electronic signature or an enhanced unqualified electronic signature of the applicant.
57. Ensuring the organization of work on the formation and maintenance of the nomenclature classification of medical devices by type shall be carried out by the registration authority.
58. When the type of a medical device is changed as part of the work on the formation and maintenance of the nomenclature classification of medical devices by type, the registration authority shall notify the applicant through the applicant’s electronic account of the planned change to the type contained in the registry entry.
Within 15 working days from the date of posting the notification specified in the first paragraph of this clause in the applicant’s electronic account, the applicant shall have the right to review it and, if there are objections, submit them to the registration authority through the applicant’s electronic account. Such objections shall be submitted by the applicant once.
If the applicant’s objections are not received within the established period, the registration authority shall take measures to amend the registry entry.
If the applicant’s objections regarding the change of the type of the medical device are received through the applicant’s electronic account within a period not exceeding 15 working days, the registration authority shall consider them within 30 working days from the date of receipt of the objections, including with the involvement of an expert institution.
If a decision is made to recognize the objections as fully or partially justified, no measures to amend the registry entry shall be taken.
If a decision is made to recognize the objections as fully or partially unjustified, the registration authority shall notify the applicant of the decision through the applicant’s electronic account (with a reasoned justification for the decision) and shall take measures to make the relevant amendments to the registry entry.
59. The time limits and sequence of administrative procedures and administrative actions of the registration authority shall be established by the administrative regulations for the provision of the state service of state registration of medical devices, developed in accordance with the requirements established by the Government of the Russian Federation.
60. The following shall not be permitted in the territory of the Russian Federation:
a) registration of different medical devices under the same name;
b) registration as medical devices of products whose name is contained in the State Register of Medicinal Products for Medical Use, the Unified Register of Registered Medicinal Products of the Eurasian Economic Union, or coincides with the name of a biologically active food supplement, information about which is contained in the Unified Register of State Registration Certificates for Products. If a medicinal product or biologically active food supplement is a component of a medical device, their names may be used in the name of the medical device;
c) repeated registration by one manufacturer of the same medical device under a different name.
61. For the purpose of undergoing the state registration procedure for a medical device, the manufacturer (producer) of the medical device shall ensure that the medical device complies with the following requirements (as applicable):
a) restriction of interchangeability of medical devices through the use of special technical or software means or by other means shall not be permitted if this is not intended to ensure the safety and effectiveness of the medical device;
b) confirmation of the possibility of joint use of the medical device being registered with another medical device of a different manufacturer (producer), registered in accordance with the requirements of the legislation of the Russian Federation in the field of state registration of medical devices, shall be permitted. In this case, the joint use of the medical device being registered with a medical device of another manufacturer (producer) shall be carried out taking into account the specific features established in the manufacturer’s (producer’s) operational documentation for the medical device being registered.
62. Decisions and actions (inaction) of the registration authority that have resulted in a violation of the rights of a legal entity or an individual registered as an individual entrepreneur, as well as opinions of the expert institution based on the results of examinations conducted by it in accordance with these Rules, may be appealed by the applicant in accordance with the procedure established by the legislation of the Russian Federation.
II. State Registration of Medical Devices, Confirmation of the Effectiveness of Which Requires Clinical Trials Involving Human Subjects and Obtaining a Permit from the Registration Authority to Conduct Clinical Trials
Paragraph 63 was effective until 31.12.2025 and applies from 08.01.2026 until 31.12.2027 (paragraph 2*** of Resolution of the Government of the Russian Federation No. 2214 dated 30.12.2025).***
63. For the state registration of a medical device, confirmation of the effectiveness of which requires clinical trials involving human subjects and obtaining a permit from the registration authority to conduct clinical trials, the applicant shall submit to the registration authority, through the applicant’s unified personal account, an application for registration, as well as the documents specified in paragraph 65 of these Rules.
64. The following information shall be specified in the application for registration:
a) the name of the medical device (indicating the models (brands) of the medical device, their composition and accessories necessary for the intended use of the medical device or its models (brands), if any), while the applicant shall indicate the trademark and other means of individualization of the medical device if they are affixed to the packaging of the medical device;
b) with regard to the manufacturer (producer) of the medical device:
for a legal entity — the full and abbreviated (if any) names (with transliteration), legal form, taxpayer identification number (for manufacturers that are residents of the Russian Federation), registered address, as well as telephone number and e-mail address;
for an individual registered as an individual entrepreneur — surname, first name and patronymic (if any), details of the identity document, taxpayer identification number (for manufacturers that are residents of the Russian Federation), residential address, as well as telephone number and e-mail address;
c) with regard to the authorized representative of the manufacturer (producer):
for a legal entity — the full and abbreviated (if any) names (with transliteration), legal form, taxpayer identification number, registered address, as well as telephone number and e-mail address;
for an individual registered as an individual entrepreneur — surname, first name and patronymic (if any), details of the identity document, taxpayer identification number, residential address, as well as telephone number and e-mail address;
d) the name(s) (with transliteration) of the production site(s), the address(es) of its (their) location;
e) the intended purpose of the medical device established by the manufacturer (producer) in accordance with the technical and operational documentation for the medical device;
f) the type or types of the medical device in accordance with the nomenclature classification of medical devices by type in the case provided for by paragraph 26 of these Rules;
g) the class of potential risk of use of the medical device in accordance with the nomenclature classification of medical devices by classes depending on the potential risk of their use, approved by the Ministry of Health of the Russian Federation;
h) the code of the All-Russian Classifier of Products by Types of Economic Activity (hereinafter referred to as the classifier);
i) information on the possibility (impossibility) of classifying the medical device as:
software that is a medical device;
software using artificial intelligence technologies that is a medical device;
j) information on the presence (absence) of direct or indirect contact of the medical device and/or its accessories with the surface of the human body, its mucous membranes, internal body environments, for which such interaction (contact) is necessary to perform their intended function;
k) information on whether the medical device is classified as measuring instruments in the sphere of state regulation of ensuring the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation;
l) the number and date of the protocol of technical tests of the medical device, as well as the name of the testing laboratory that issued the test protocol and information on the registration entry number of such laboratory in the register of accredited persons;
m) the number and date of the protocol of toxicological studies of the medical device and/or accessories to the medical device that directly or indirectly come into contact with the surface of the human body, its mucous membranes, internal body environments, for which such interaction (contact) is necessary to perform their intended functions, as well as the name of the testing laboratory that issued the study protocol and information on its registration entry number in the register of accredited persons;
n) the number and date of the protocol of tests of the medical device for the purpose of type approval of measuring instruments (with regard to medical devices classified as measuring instruments in the sphere of state regulation of ensuring the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation), as well as the name of the testing laboratory that issued the test protocol and information on its registration entry number in the register of accredited persons;
o) the date and number of the inspection report, its validity period, as well as the name of the organization that conducted the inspection (specified in the case of an inspection conducted by an inspecting organization under the authority (subordination) of the registration authority);
p) information on the necessity (absence of necessity) of conducting clinical trials involving human subjects;
q) information on the presence (absence) in the composition of the medical device of a medicinal product, pharmaceutical substance, biological material and other active substance;
r) information on the release of the device in sterile (non-sterile) form;
s) details of the document(s) confirming the manufacturer’s (producer’s) right to use the trademark and other means of individualization of the medical device if they are affixed to the packaging of the medical device;
t) information on payment of the state duty (date and number of the payment order(s));
u) information on the registration number and date of state registration of the medical device (amendments to the documents contained in the registration dossier) (as applicable);
v) information on the possibility (impossibility) of classifying the medical device as an in vitro diagnostic medical device;
w) information on notifications of importation of the medical device for the purpose of its state registration submitted to the registration authority;
x) information on the applicant’s responsibility for the accuracy and identity of the information contained in the registration dossier and the application for registration.
65. For the state registration of a medical device, confirmation of the effectiveness of which requires clinical trials involving human subjects and obtaining a permit from the registration authority to conduct clinical trials, the following documents shall be submitted:
a) a copy (copies) of the document(s) confirming the authority of the authorized representative of the manufacturer (producer) to represent the interests of the manufacturer (producer), bear responsibility with regard to the circulation of the medical device in the territory of the Russian Federation, including matters concerning conformity assessment procedures and state registration of the medical device, as well as to certify documents of the manufacturer (producer) that entered into force prior to the preparation of the relevant documents (the document(s) is/are mandatory for foreign manufacturers (producers); for domestic manufacturers (producers), the document(s) shall be submitted if there is an authorized representative of the manufacturer (producer));
b) information on the regulatory documentation for the medical device;
c) technical documentation of the manufacturer (producer) for the medical device;
d) operational documentation of the manufacturer (producer) for the medical device, including instructions for use or an operating manual for the medical device;
e) color photographic images of the general appearance of the medical device, models (brands) of the medical device and accessories necessary for the intended use of the medical device (size not less than 18 × 24 centimeters), as well as images of the labeling and packaging (color layouts of packaging and labels containing the text of the original labeling and additional labeling in Russian applied to medical devices manufactured outside the Russian Federation);
f) a draft description of the type of the measuring instrument that is a medical device (with regard to medical devices classified as measuring instruments in the sphere of state regulation of ensuring the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation);
g) a verification methodology for the type of measuring instrument that is a medical device (with regard to medical devices classified as measuring instruments in the sphere of state regulation of ensuring the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation);
h) a draft plan for clinical trials of the medical device involving human subjects with supporting materials (if available);
i) documents confirming the possibility of carrying out production at the address(es) specified in the application for registration as the production site(s) (as applicable): documents confirming the availability of production conditions, and/or copies of certificates of conformity of the quality management system with the requirements of interstate standard GOST ISO 13485-2017 “Medical Devices. Quality Management Systems. Requirements for Regulatory Purposes”, approved and put into effect on June 1, 2018 (hereinafter referred to as GOST ISO 13485-2017), or the corresponding international standard ISO 13485:2016 “Medical Devices. Quality Management Systems. Requirements for Regulatory Purposes” (hereinafter referred to as ISO 13485:2016), as well as copies of reports on previously conducted inspections for compliance with the specified standards (if the specified certificates of conformity are submitted), and/or copies of documents confirming compliance of the quality management system with the requirements for the implementation, maintenance and assessment of the quality management system for medical devices (submitted in the case of an inspection conducted by an inspecting organization under the authority (subordination) of a state authority of a member state of the Eurasian Economic Union authorized to carry out and/or coordinate activities in the sphere of circulation of medical devices in the territory of that state, except for the Russian Federation);
j) documents confirming the manufacturer’s (producer’s) right to use the trademark and other means of individualization of the medical device if they are affixed to the packaging of the medical device (submitted if the information has not been entered into the relevant registers of the Federal Service for Intellectual Property);
k) copies of documents confirming the quality of the medicinal product, pharmaceutical substance, biological material and other substance with which the medical device was manufactured or which are included in its composition and are intended for use only taking into account the intended purpose of the medical device determined by the manufacturer, issued in accordance with the legislation of the country of origin of the medicinal product, pharmaceutical substance, biological material and other substance;
l) a copy of the document confirming the registration of the manufacturer (producer) as a legal entity or individual entrepreneur (except for medical devices manufactured by manufacturers that are residents of the Russian Federation);
m) a clinical monitoring plan (for medical devices of potential risk class 3, as well as medical devices implanted into the human body, of potential risk class 26);
n) evidentiary materials of the manufacturer (producer) of the medical device (as applicable):
evidentiary materials of the manufacturer (producer) of the medical device regarding the determination of the quality and safety of the medical device, compliance of its characteristics (properties) with the requirements of regulatory documentation, technical and operational documentation of the manufacturer (producer);
evidentiary materials of the manufacturer (producer) of the medical device regarding studies for the assessment of the biological safety of the medical device.
66. The registration authority shall not have the right to require the applicant to indicate in the application for registration information not provided for by paragraph 64 of these Rules or to submit documents not provided for by paragraph 65 of these Rules.
The applicant shall have the right, on its own initiative, to submit documents, information about which is specified in the application for registration in accordance with subparagraphs “l”–“o”, “s” and “w” of paragraph 64 of these Rules.
The applicant shall have the right to submit other necessary documents on its own initiative.
67. Within 5 working days from the date of receipt of the application for registration and the documents provided for by paragraph 65 of these Rules, the registration authority shall verify the completeness and accuracy of the information contained therein, including by comparing such information with information submitted by state authorities through interdepartmental information exchange using the system of interdepartmental electronic interaction.
68. If the application for registration has been prepared in violation of the provisions of paragraph 64 of these Rules, and/or the submitted documents have been prepared in violation of the provisions of paragraphs 53–55 of these Rules, and/or inaccurate information is specified in the application for registration and the submitted documents, or the documents provided for by paragraph 65 of these Rules have not been submitted in full, the registration authority shall notify the applicant of the need to eliminate the identified violations and/or submit the missing documents within 30 working days from the date of posting such notification, in the form of an electronic document signed with an enhanced qualified electronic signature of an authorized official, in the applicant’s unified personal account and the applicant’s electronic account. The applicant shall eliminate the identified violations and/or submit the missing documents through the applicant’s unified personal account.
The period from the date the registration authority notifies the applicant until the date of receipt of a response to the notification or notification of failure to provide a response to the request shall not be taken into account when calculating the period for state registration of the medical device.
69. Within 2 working days from the date of completion of the verification provided for by paragraph 67 of these Rules (in the case of submission of a duly completed application for registration and all documents provided for by paragraph 65 of these Rules), as well as in the event that the identified violations are eliminated within a period not exceeding 30 working days and/or the documents provided for by paragraph 65 of these Rules are submitted, the registration authority shall make a decision to commence the state registration of the medical device.
70. If the identified violations are not eliminated and/or the missing documents are not submitted within a period not exceeding 30 working days, including taking into account the provision of paragraph 53 of these Rules, the registration authority shall make a decision to terminate further consideration of the application for registration and the documents provided for by paragraph 65 of these Rules and shall inform the applicant thereof by posting the relevant notification, in the form of an electronic document signed with an enhanced qualified electronic signature of an authorized official, in the applicant’s unified personal account and the applicant’s electronic account, with a reasoned justification for the reasons for such decision.
71. State registration of medical devices, confirmation of the effectiveness of which requires clinical trials involving human subjects and obtaining a permit from the registration authority to conduct clinical trials, shall be carried out by the registration authority within a period not exceeding 50 working days from the date of receipt of the application for registration and the documents provided for by paragraph 65 of these Rules.
The period for conducting clinical trials of a medical device involving human subjects shall not be included in the specified 50-day period.
72. Within 2 working days from the date of making the decision to commence the state registration of the medical device, the registration authority shall prepare and issue an assignment for conducting an examination of the quality, effectiveness and safety of the medical device to the expert institution (hereinafter referred to as the assignment for conducting the examination).
73. The examination of the quality, effectiveness and safety of a medical device, confirmation of the effectiveness of which requires clinical trials involving human subjects and obtaining a permit from the registration authority to conduct clinical trials, shall be conducted by the expert institution in stages in accordance with the procedure approved by the Ministry of Health of the Russian Federation:
a) at Stage I, an examination of the application for registration and the documents specified in paragraph 65 of these Rules shall be carried out to determine the possibility (impossibility) of conducting clinical trials of the medical device involving human subjects;
b) at Stage II, an examination of the completeness and results of the technical tests, toxicological studies, clinical trials, tests for the purpose of type approval of measuring instruments (with regard to medical devices classified as measuring instruments in the sphere of state regulation of ensuring the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation), inspection of production, as well as an analysis of the evidentiary materials of the manufacturer (producer) of the medical device (hereinafter referred to as the examination of the completeness and results of tests and studies) shall be carried out.
74. During the examination of the quality, effectiveness and safety of a medical device (at any stage), the expert institution shall not request from the applicant or other persons materials necessary for conducting the examination.
If the materials and information contained in the application for registration and the documents submitted by the applicant and provided for by paragraph 65 of these Rules are insufficient for the expert of the expert institution (hereinafter referred to as the expert) to issue an opinion, the expert shall raise the issue of providing the necessary materials and information with the head of the expert institution, who shall submit a corresponding request to the registration authority that issued the assignment for conducting the examination. The said request shall contain an exhaustive list of all questions, materials and information necessary for the expert to conduct the examination.
Within 2 working days from the date of receipt of the request from the head of the expert institution, the registration authority shall send the applicant a request to provide the necessary materials and information, specifying the nature of the comments and the method of eliminating them. The said request shall be sent once at each stage of the examination of the quality, effectiveness and safety of the medical device in the form of an electronic document signed with an enhanced qualified electronic signature of an authorized official, by posting it in the applicant’s electronic account and the applicant’s unified personal account.
The applicant shall submit a response to the request of the registration authority through the applicant’s unified personal account within a period not exceeding 50 working days from the date of sending the request. Within 2 working days from the date of receipt of the applicant’s response to the request, the registration authority shall forward the response to the expert institution. If the applicant fails to submit a response to the request after the expiry of 50 working days, the registration authority shall, within 2 working days, send the expert institution a notification that the applicant has failed to provide a response to the request of the registration authority, for the preparation of the expert institution’s opinion on the basis of the documents available to it.
The period from the date of sending the request by the registration authority until the date of receipt of the response to the request or notification of failure to provide a response to the request shall not be taken into account when calculating the period for conducting the examination of the quality, effectiveness and safety of the medical device.
If the registration authority identifies inaccurate and/or insufficient information in the documents submitted by the applicant in response to the request of the registration authority and/or non-compliance of the submitted documents with the provisions of paragraphs 53–55 of these Rules, the registration authority shall, within 2 working days, send the applicant (in the form of an electronic document signed with an enhanced qualified electronic signature of an authorized official, by posting it in the applicant’s electronic account and the applicant’s unified personal account) a reasoned decision on the possibility of resubmitting revised documents by the applicant before the expiry of 50 working days from the date of sending the request. If the applicant fails to submit the requested materials and information within the specified period, the examination of the quality, effectiveness and safety of the medical device shall continue on the basis of the documents and information previously submitted by the applicant and available to the expert institution and contained in the registration dossier.
75. At Stage I of the examination of the quality, effectiveness and safety of the medical device, the expert institution shall, within a period not exceeding 17 working days from the date of receipt of the assignment for conducting the examination, carry out the following activities:
a) conduct an examination of the application for registration and the documents provided for by paragraph 65 of these Rules to determine the possibility (impossibility) of conducting clinical trials of the medical device involving human subjects;
b) prepare and submit to the registration authority an opinion on the possibility (impossibility) of conducting clinical trials of the medical device involving human subjects (indicating the reasons and justification for the impossibility of conducting them), the form of which is approved by the Ministry of Health of the Russian Federation (hereinafter referred to as the opinion on conducting clinical trials of the medical device).
76. The grounds for the expert institution to issue an opinion on conducting clinical trials of the medical device stating the impossibility of conducting clinical trials of the medical device involving human subjects shall be:
a) non-compliance of the medical device with the requirements of regulatory documentation, technical and/or operational documentation of the manufacturer (producer);
b) lack of evidence of the safety of the medical device;
c) presence of inaccurate information in the documents contained in the registration dossier.
77. Within 5 working days from the date of receipt from the expert institution of the opinion on conducting clinical trials of the medical device, the registration authority shall carry out the following activities:
a) assessment of the opinion on conducting clinical trials of the medical device to determine its compliance with the assignment for conducting the examination. If non-compliance of the opinion on conducting clinical trials of the medical device with the assignment is established, such opinion shall be returned to the expert institution for revision, the period of which shall not exceed 2 working days from the date of receipt by the expert institution of the returned opinion on conducting clinical trials of the medical device;
b) in the event of receipt of the opinion on conducting clinical trials of the medical device provided for by paragraph 76 of these Rules, no later than the next working day after the assessment of the opinion on conducting clinical trials of the medical device to determine its compliance with the assignment for conducting the examination, the registration authority shall post an electronic image of the opinion on conducting clinical trials of the medical device that complies with the assignment for conducting the examination in the applicant’s electronic account and send the relevant information to the applicant’s unified personal account.
Within 10 working days from the date of posting in the applicant’s electronic account the opinion on conducting clinical trials of the medical device specified in paragraph 76 of these Rules, the applicant shall have the right to review the opinion on conducting clinical trials of the medical device and, if there are objections, submit its objections to the opinion on conducting clinical trials of the medical device through the applicant’s electronic account.
If the applicant’s objections to the opinion on conducting clinical trials of the medical device provided for by paragraph 76 of these Rules are received through the applicant’s electronic account within a period not exceeding 10 working days, the registration authority shall, within 30 working days from the date of receipt of the objections, consider them with the involvement of the expert institution that issued the relevant opinion on conducting clinical trials of the medical device. If the applicant’s objections are not received within the established period, the registration authority shall carry out the activities provided for by subparagraphs “c” and “d” of this paragraph. When considering the objections, the registration authority shall, if necessary, involve the applicant to provide explanations.
Following consideration of the objections, a decision shall be made to recognize the objections as fully or partially justified, which shall be formalized by a letter from the registration authority and sent to the expert institution together with the opinion on conducting clinical trials of the medical device provided for by paragraph 76 of these Rules for revision, the period of which shall not exceed 5 working days from the date of receipt by the expert institution of the returned opinion on conducting clinical trials of the medical device, or to recognize the objections as completely unjustified.
The period from the date the registration authority posts in the applicant’s electronic account the opinion on conducting clinical trials of the medical device specified in paragraph 76 of these Rules until the decision is made following consideration of the objections shall not be taken into account when calculating the period for conducting the examination of the quality, effectiveness and safety of the medical device;
c) making a decision to issue a permit for conducting clinical trials of the medical device or to refuse state registration of the medical device, which shall be formalized by an order of the registration authority, and informing the applicant of the decision made by posting the relevant notification in the form of an electronic document signed with an enhanced qualified electronic signature of an authorized official in the applicant’s unified personal account and the applicant’s electronic account;
d) making an entry in the register of issued permits for conducting clinical trials of the medical device, the procedure for maintaining which shall be approved by the registration authority.
78. When making a decision to issue a permit for conducting clinical trials of the medical device, the registration authority shall make a decision to suspend the state registration procedure for the medical device until the date on which the registration authority makes a decision to resume the state registration of the medical device in accordance with paragraph 81 of these Rules.
79. Regarding clinical trials of the medical device involving human subjects, the applicant shall notify the registration authority through the applicant’s unified personal account within 5 working days from the start of their conduct.
80. Upon completion of clinical trials of the medical device involving human subjects, the applicant shall submit to the registration authority through the applicant’s unified personal account an application for resumption of state registration of the medical device, an application for registration prepared in accordance with paragraph 64 of these Rules containing updated information (if necessary) and information on the results of clinical trials of the medical device involving human subjects (with regard to clinical trials completed before September 1, 2025, the information shall be submitted in the form of documents), as well as the documents specified in subparagraphs “b”–“g” and “n” of paragraph 65 of these Rules if amendments have been made to them based on the results of clinical trials of the medical device involving human subjects, as well as updated documents provided for by subparagraphs “a”, “i” and “l” of paragraph 65 of these Rules (if necessary).
The applicant shall have the right to submit, on its own initiative, the documents, information about which is specified in the application for registration in accordance with subparagraphs “l”–“o”, “s” and “w” of paragraph 64 of these Rules (if amendments have been made to them), as well as documents confirming the results of clinical trials completed after September 1, 2025.
81. Within 2 working days from the date of receipt of the documents specified in paragraph 80 of these Rules, the registration authority shall make a decision to resume the state registration of the medical device.
The decision to resume the state registration of the medical device shall be made by the registration authority based on the results of verification of the completeness and accuracy of the information contained in the application for resumption of state registration of the medical device and other documents specified in paragraph 80 of these Rules submitted to the registration authority.
If these documents are not submitted in full or inaccurate data are identified therein, as well as if non-compliance of the submitted documents with the provisions of paragraphs 53–55 of these Rules is identified, the registration authority shall send the applicant (in the form of an electronic document signed with an enhanced qualified electronic signature of an authorized official, by posting it in the applicant’s unified personal account and the applicant’s electronic account) a decision to terminate further consideration of the application for resumption of state registration of the medical device with a reasoned justification for the reasons for such decision. At the same time, the registration authority shall inform the applicant of the possibility of resubmitting the application for resumption of state registration of the medical device with revised documents attached through the applicant’s unified personal account.
82. At Stage II of the examination of the quality, effectiveness and safety of the medical device, within 2 working days from the date of making the decision to resume the state registration of the medical device, the registration authority, on the basis of the assignment for conducting the examination issued in accordance with paragraph 72 of these Rules, shall send to the expert institution the results of the clinical trials of the medical device involving human subjects submitted by the applicant, as well as other documents submitted by the applicant in accordance with paragraph 80 of these Rules.
83. Within a period not exceeding 8 working days from the date of receipt of the documents specified in paragraph 80 of these Rules, the expert institution shall conduct an examination of the completeness and results of the tests and studies conducted, and shall prepare and submit to the registration authority an opinion based on the results of the examination of the quality, effectiveness and safety of the medical device, the form of which is approved by the Ministry of Health of the Russian Federation.
84. The grounds for the expert institution to issue an opinion based on the results of the examination of the quality, effectiveness and safety of the medical device stating the impossibility of state registration of the medical device shall be:
a) non-compliance of the medical device with the requirements of regulatory documentation, technical and/or operational documentation of the manufacturer (producer);
b) lack of evidence of the quality, and/or effectiveness, and/or safety of the medical device;
c) establishment that the risk of harm to the health of citizens and medical workers as a result of the use of the medical device exceeds the effectiveness of its use;
d) submission of inaccurate information in the documents contained in the registration dossier.
85. Within a period not exceeding 7 working days from the date of receipt of the opinion based on the results of the examination of the quality, effectiveness and safety of the medical device, the registration authority shall carry out the following activities:
a) assessment of the opinion based on the results of the examination of the quality, effectiveness and safety of the medical device specified in paragraph 83 of these Rules to determine its compliance with the assignment for conducting the examination. If non-compliance of the opinion based on the results of the examination of the quality, effectiveness and safety of the medical device with the said assignment is established, such opinion shall be returned to the expert institution for revision, the period of which shall not exceed 2 working days from the date of receipt by the expert institution of the returned opinion based on the results of the examination of the quality, effectiveness and safety of the medical device;
b) in the event of receipt of the opinion based on the results of the examination of the quality, effectiveness and safety of the medical device provided for by paragraph 84 of these Rules, no later than the next working day after the assessment of such opinion to determine its compliance with the assignment for conducting the examination, the registration authority shall post an electronic image of the opinion based on the results of the examination of the quality, effectiveness and safety of the medical device that complies with the assignment for conducting the examination in the applicant’s electronic account and send the relevant information to the applicant’s unified personal account.
Within 10 working days from the date of posting in the applicant’s electronic account the opinion based on the results of the examination of the quality, effectiveness and safety of the medical device specified in paragraph 84 of these Rules, the applicant shall have the right to review the opinion based on the results of the examination of the quality, effectiveness and safety of the medical device and, if there are objections, submit its objections to such opinion through the applicant’s electronic account.
If the applicant’s objections to the opinion based on the results of the examination of the quality, effectiveness and safety of the medical device provided for by paragraph 84 of these Rules are received through the applicant’s electronic account within a period not exceeding 10 working days, the registration authority shall, within 30 working days from the date of receipt of the objections, consider them with the involvement of the expert institution that issued this opinion. If the applicant’s objections are not received within the established period, the registration authority shall carry out the activities provided for by subparagraphs “c” and “d” of this paragraph. When considering the objections, the registration authority shall, if necessary, involve the applicant to provide explanations.
Following consideration of the objections, a decision shall be made to recognize the objections as fully or partially justified, which shall be formalized by a letter from the registration authority and sent to the expert institution together with the opinion based on the results of the examination of the quality, effectiveness and safety of the medical device provided for by paragraph 84 of these Rules requiring revision, the period of which shall not exceed 5 working days from the date of receipt by the expert institution of the returned opinion, or to recognize the objections as completely unjustified.
The period from the date the registration authority posts in the applicant’s electronic account the opinion based on the results of the examination of the quality, effectiveness and safety of the medical device specified in paragraph 84 of these Rules until the decision is made following consideration of the objections shall not be taken into account when calculating the period for conducting the examination of the quality, effectiveness and safety of the medical device;
c) making a decision on the state registration of the medical device or refusal of state registration of the medical device, which shall be formalized by an order of the registration authority, and informing the applicant of the decision made by posting the relevant notification in the form of an electronic document signed with an enhanced qualified electronic signature of an authorized official in the applicant’s unified personal account and the applicant’s electronic account;
d) making a registry entry in the state register.
86. The grounds for the registration authority to make a decision to refuse state registration of a medical device shall be:
a) receipt by the registration authority from the expert institution of an opinion on conducting clinical trials of the medical device stating the impossibility of conducting clinical trials of the medical device involving human subjects;
b) receipt from the expert institution of an opinion based on the results of the examination of the quality, effectiveness and safety of the medical device stating the impossibility of state registration of the medical device, and/or the registration authority’s decision to recognize the applicant’s objections as fully or partially unjustified;
c) identification by the registration authority, based on the results of federal state control (supervision) over the circulation of medical devices, of discrepancies between the data on the effectiveness and safety of the medical device and the data on the medical device contained in the application for registration and the documents specified in paragraphs 65 and 80 of these Rules.
III. State Registration of Medical Devices for Which Confirmation of Effectiveness Does Not Require Conducting Clinical Trials Involving Human Subjects or Obtaining Authorization from the Registration Authority to Conduct Such Clinical Trials
Clause 87 was in effect until 31 December 2025 and applies from 8 January 2026 until 31 December 2027 (clause 2*** of Resolution of the Government of the Russian Federation No. 2214 dated 30 December 2025).***
87. For the state registration of a medical device for which confirmation of effectiveness does not require conducting clinical trials involving human subjects or obtaining authorization from the registration authority to conduct such clinical trials, the applicant shall, through the unified applicant personal account, submit to the registration authority an application for registration drawn up in accordance with Clause 64 of these Rules and additionally containing information on whether or not software using artificial intelligence technologies that is a medical device has a built-in function for the automatic transmission, in accordance with the procedure approved by the registration authority, to the automated information system of the registration authority of information on the data being processed and the results of operation of the software using artificial intelligence technologies that is a medical device, as well as information provided for by the procedure for reporting by entities involved in the circulation of medical devices on all cases of detection of adverse effects not specified in the instructions for use or operating manual of the medical device, adverse reactions to its use, specific features of interaction between medical devices, and facts and circumstances creating a threat to the life and health of citizens and medical workers during the use and operation of medical devices, approved by the Ministry of Health of the Russian Federation (hereinafter referred to as the procedure for reporting by entities involved in the circulation of medical devices on all cases of detection of adverse effects), as well as information on the results of clinical trials of the medical device (without human participation), indicating the number and date of the act of evaluation of the results of clinical trials of the medical device, the name of the medical organization, and the following documents:
a) a copy (copies) of the document(s) confirming the powers of the authorized representative of the manufacturer to represent the interests of the manufacturer, bear responsibility with respect to the circulation of the medical device in the territory of the Russian Federation, including with respect to conformity assessment procedures and state registration of the medical device, as well as to certify the manufacturer’s document(s) that entered into force prior to the preparation of the respective document(s) (the document(s) shall be mandatory for foreign manufacturers; domestic manufacturers shall submit the document(s) where an authorized representative of the manufacturer exists);
b) information on the regulatory documentation for the medical device;
c) the manufacturer’s technical documentation for the medical device;
d) the manufacturer’s operational documentation for the medical device, including the instructions for use or operating manual of the medical device;
e) color photographic images of the general appearance of the medical device, models (brands) of the medical device and accessories necessary for the intended use of the medical device (at least 18 × 24 centimeters in size), as well as images of the labeling and packaging (color layouts of packaging and labels containing the text of the original labeling and additional labeling in Russian applied to medical devices manufactured outside the Russian Federation) (except for software that is a medical device);
f) color photographic images of the electronic medium and software interface (at least 18 × 24 centimeters in size) (for software that is a medical device), as well as images of the labeling and packaging (if any);
g) a draft description of the type of measuring instrument that is a medical device (with respect to medical devices classified as measuring instruments within the sphere of state regulation of ensuring the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation);
h) the verification procedure for the type of measuring instrument that is a medical device (with respect to medical devices classified as measuring instruments within the sphere of state regulation of ensuring the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation);
i) documents confirming the results of clinical trials of medical devices (as applicable, depending on the date):
documents confirming the results of clinical trials (with respect to clinical trials completed before 1 September 2025);
documents confirming the results of clinical trials (with respect to clinical trials completed after 1 September 2025) (at the applicant’s initiative);
k) documents confirming the possibility of carrying out production at the address(es) specified in the registration application as the production site(s) (as applicable): documents confirming the availability of production conditions, and/or copies of certificates of conformity of the quality management system with the requirements of GOST ISO 13485-2017 or ISO 13485:2016, as well as copies of reports on inspections previously conducted for compliance with the said standards (where the said certificates of conformity are submitted), and/or copies of documents confirming the compliance of the quality management system with the requirements for the implementation, maintenance and assessment of the quality management system for medical devices (submitted where an inspection is conducted by an inspecting organization under the authority (subordination) of a state authority of a Member State of the Eurasian Economic Union authorized to carry out and/or coordinate activities in the sphere of circulation of medical devices in the territory of that state, except for the Russian Federation);
l) documents confirming the manufacturer’s right to use the trademark and other means of individualization of the medical device where they are applied to the packaging of the medical device (provided if the information has not been entered in the relevant registers of the Federal Service for Intellectual Property);
m) copies of documents confirming the quality of the medicinal product, pharmaceutical substance, biological material and other substance with which the medical device was manufactured or which are included in its composition and are intended for use only taking into account the intended purpose of the medical device determined by the manufacturer, issued in accordance with the legislation of the country of origin of the medicinal product, pharmaceutical substance, biological material and other substance (except for in vitro diagnostic medical devices);
n) a copy of the document confirming registration of the manufacturer as a legal entity or individual entrepreneur (except for medical devices whose manufacturers are residents of the Russian Federation);
o) a clinical monitoring plan (for medical devices of potential risk class 3, as well as medical devices implanted in the human body, of potential risk class 26);
p) evidentiary materials of the manufacturer of the medical device (as applicable):
evidentiary materials of the manufacturer of the medical device with respect to determining the quality and safety of the medical device, compliance of its characteristics (properties) with the requirements of regulatory documentation and the manufacturer’s technical and operational documentation;
evidentiary materials of the manufacturer of the medical device with respect to studies for the purpose of assessing the biological safety of the medical device.
88. The registration authority shall not have the right to require the applicant to indicate in the registration application information not provided for by Clause 64 of these Rules or to submit documents not provided for by Clause 87 of these Rules.
The applicant shall have the right, on its own initiative, to submit documents, information on which is indicated in the registration application in accordance with subparagraphs “m”–”p”, “u” and “ch” of Clause 64 of these Rules.
The applicant shall have the right, on its own initiative, to submit other necessary documents.
89. Within 5 working days from the date of receipt of the registration application and the documents provided for by Clause 87 of these Rules, the registration authority shall verify the completeness and reliability of the information contained therein, including by comparing such information with information submitted by state authorities in accordance with the procedure for interdepartmental information interaction through the system of interdepartmental electronic interaction.
90. If the registration application has been drawn up in violation of the provisions of Clause 64 of these Rules, and/or the submitted documents have been drawn up in violation of the provisions of Clauses 53–55 of these Rules, and/or unreliable information is indicated in the registration application and the submitted documents, or the documents provided for by Clause 87 of these Rules have not been submitted in full, the registration authority shall notify the applicant of the need to eliminate the identified violations and/or submit the missing documents within 30 working days from the date of placement of such notification, in the form of an electronic document signed with an enhanced qualified electronic signature of an authorized official, in the unified applicant personal account and the applicant’s electronic account. The applicant shall eliminate the identified violations and/or submit the missing documents through the unified applicant personal account.
The time from the date of notification of the applicant by the registration authority until the date of receipt of a response to the notification or notification of failure to provide a response to the respective request shall not be taken into account when calculating the period for state registration of the medical device.
91. Within 3 working days from the date of completion of the verification provided for by Clause 89 of these Rules (where a duly completed registration application and all documents provided for by Clause 87 of these Rules have been submitted), as well as where the identified violations have been eliminated and/or the documents provided for by Clause 87 of these Rules have been submitted within a period not exceeding 30 working days, the registration authority shall take a decision to commence the state registration of the medical device.
92. If the identified violations have not been eliminated and/or the missing documents have not been submitted within a period not exceeding 30 working days, including taking into account the provision of Clause 53 of these Rules, the registration authority shall take a decision to terminate further consideration of the registration application and the documents provided for by Clause 87 of these Rules and shall inform the applicant thereof by placing the relevant notification, with a reasoned justification of the reasons for taking the said decision, in the form of an electronic document signed with an enhanced qualified electronic signature of an authorized official, in the unified applicant personal account and the applicant’s electronic account.
93. State registration of medical devices for which confirmation of effectiveness does not require conducting clinical trials involving human subjects or obtaining authorization from the registration authority to conduct such clinical trials shall be carried out by the registration authority within a period not exceeding 31 working days from the date of receipt of the registration application and the documents provided for by Clause 87 of these Rules.
94. Within 3 working days from the date of taking the decision to commence the state registration of the medical device, the registration authority shall prepare and issue an assignment for conducting an examination to the expert institution.
95. With respect to medical devices for which confirmation of effectiveness does not require conducting clinical trials involving human subjects or obtaining authorization from the registration authority to conduct such clinical trials, the examination of the registration application and the documents specified in Clause 87 of these Rules shall be carried out simultaneously with the examination of the completeness and results of tests and studies within a period not exceeding 10 working days from the date of receipt by the expert institution of the relevant assignment from the registration authority.
96. When conducting the examination of the quality, effectiveness and safety of a medical device, the expert institution shall not be permitted to request from the applicant or other persons materials necessary for conducting the examination.
If the materials and information contained in the registration application and the documents provided by the applicant under Clause 87 of these Rules are insufficient for the expert to issue an opinion, the expert shall raise the issue of providing the necessary materials and information with the head of the expert institution, who shall submit a corresponding request to the registration authority that issued the assignment for conducting the examination. The said request shall contain an exhaustive list of all questions, materials and information necessary for the expert to conduct the examination.
Within 2 working days from the date of receipt of the request from the head of the expert institution, the registration authority shall send the applicant a request to provide the necessary information, indicating the nature of the comments and the method for eliminating them. The said request shall be sent once and delivered to the applicant in the form of an electronic document signed with an enhanced qualified electronic signature of an authorized official, by placing it in the applicant’s electronic account and the unified applicant personal account.
The applicant shall submit a response to the request of the registration authority through the unified applicant personal account within a period not exceeding 50 working days from the date of sending this request. Within 2 working days from the date of receipt of the applicant’s response to the request, the registration authority shall forward such response to the expert institution. If the applicant fails to submit a response to the request after 50 working days have elapsed, the registration authority shall, within 2 working days, send the expert institution a notification of the applicant’s failure to provide a response to the request of the registration authority so that the expert institution may prepare an opinion based on the documents at its disposal.
The time from the date of sending the request of the registration authority until the date of receipt of the response to the request or notification of failure to provide a response to the request shall not be taken into account when calculating the period for conducting the examination of the quality, effectiveness and safety of the medical device.
If the registration authority identifies, in the documents submitted by the applicant in response to the request of the registration authority, unreliable and/or insufficient information or documents and/or non-compliance of the submitted documents with the provisions of Clauses 53–55 of these Rules, the registration authority shall, within 2 working days, send the applicant (in the form of an electronic document signed with an enhanced qualified electronic signature of an authorized official, by placing it in the unified applicant personal account and the applicant’s electronic account) a reasoned decision on the possibility for the applicant to resubmit amended documents before the expiry of 50 working days from the date of sending the request. If the applicant fails to submit the requested materials and information within the specified period, the examination of the quality, effectiveness and safety of the medical device shall continue on the basis of the documents previously submitted by the applicant and the information contained in the registration dossier that are at the disposal of the expert institution.
97. Within a period not exceeding 10 working days from the date of receipt of the documents specified in Clause 87 of these Rules, the expert institution shall conduct an examination of the quality, effectiveness and safety of the medical device and shall send to the registration authority an opinion based on the results of such examination.
98. The grounds for the expert institution to issue an opinion based on the results of the examination of the quality, effectiveness and safety of the medical device indicating the impossibility of state registration of the medical device shall be:
a) non-compliance of the medical device with the requirements of the regulatory documentation and the manufacturer’s technical and/or operational documentation;
b) absence of evidence of the quality, and/or effectiveness, and/or safety of the medical device;
c) determination that the risk of harm to the health of citizens and medical workers resulting from the use of the medical device exceeds the effectiveness of its use;
d) presence of unreliable information in the documents contained in the registration dossier.
99. Within a period not exceeding 10 working days from the date of receipt of the opinion based on the results of the examination of the quality, effectiveness and safety of the medical device, the registration authority shall carry out the following measures:
a) assessment of the opinion based on the results of the examination of the quality, effectiveness and safety of the medical device specified in Clause 97 of these Rules in order to determine its compliance with the assignment for conducting the examination. If non-compliance of the opinion based on the results of the examination of the quality, effectiveness and safety of the medical device with the said assignment is established, such opinion shall be returned to the expert institution for revision, the period for which shall not exceed 2 working days from the date of receipt by the expert institution of the returned opinion;
b) if an opinion based on the results of the examination of the quality, effectiveness and safety of the medical device provided for by Clause 98 of these Rules is received, no later than the next working day after assessment of such opinion for the purpose of determining its compliance with the assignment for conducting the examination, the registration authority shall place an electronic image of the opinion based on the results of the examination of the quality, effectiveness and safety of the medical device that complies with the assignment for conducting the examination in the applicant’s electronic account and shall send the relevant information to the unified applicant personal account.
Within 10 working days from the date of placement in the applicant’s electronic account of the opinion based on the results of the examination of the quality, effectiveness and safety of the medical device specified in Clause 98 of these Rules, the applicant shall have the right to review such opinion and, if there are objections, to submit its objections through the applicant’s electronic account.
If, through the applicant’s electronic account, the applicant’s objections to the opinion based on the results of the examination of the quality, effectiveness and safety of the medical device provided for by Clause 98 of these Rules are received within a period not exceeding 10 working days, the registration authority shall, within 30 working days from the date of receipt of the objections, consider them with the involvement of the expert institution that issued the opinion based on the results of the examination of the quality, effectiveness and safety of the medical device. If the applicant’s objections are not received within the established period, the registration authority shall carry out the measures provided for by subparagraphs “c” and “d” of this Clause. When considering the objections, the registration authority shall, where necessary to provide explanations, involve the applicant.
Following consideration of the objections, the registration authority shall take a decision to recognize the objections as fully or partially substantiated, which shall be formalized by a letter of the registration authority and sent to the expert institution together with the opinion based on the results of the examination of the quality, effectiveness and safety of the medical device provided for by Clause 98 of these Rules for revision, the period for which shall not exceed 5 working days from the date of receipt by the expert institution of the returned opinion based on the results of the examination of the quality, effectiveness and safety of the medical device, or to recognize the objections as completely unsubstantiated.
The time from the date of placement by the registration authority in the applicant’s electronic account of the opinion based on the results of the examination of the quality, effectiveness and safety of the medical device specified in Clause 98 of these Rules until the taking of a decision following consideration of the objections shall not be taken into account when calculating the period for conducting the examination of the quality, effectiveness and safety of the medical device;
c) taking a decision on the state registration of the medical device or on refusal of state registration of the medical device, which shall be formalized by an order of the registration authority, and informing the applicant of the decision taken by placing the relevant notification in the form of an electronic document signed with an enhanced qualified electronic signature of an authorized official in the unified applicant personal account and the applicant’s electronic account;
d) entering a registry record in the state register.
100. The grounds for the registration authority to take a decision to refuse state registration of the medical device shall be:
a) receipt from the expert institution of an opinion based on the results of the examination of the quality, effectiveness and safety of the medical device indicating the impossibility of state registration of the medical device, and/or the registration authority’s taking of a decision to recognize the applicant’s objections as completely or partially unsubstantiated;
b) identification by the registration authority, based on the results of federal state control (supervision) over the circulation of medical devices, of discrepancies between the data on the effectiveness and safety of the medical device and the data on the medical device contained in the registration application and the documents specified in Clause 87 of these Rules.
IV. Specific Features of the State Registration of Domestic Medical Devices
Clause 101 was in effect until 31 December 2025 and applies from 8 January 2026 until 31 December 2027 (clause 2*** of Resolution of the Government of the Russian Federation No. 2214 dated 30 December 2025).***
101. For the state registration of domestic medical devices, the applicant shall submit or send to the institution, in hard-copy form, the following documents and information:
a) an application for conducting an examination of the quality, effectiveness and safety of the medical device, containing information in accordance with Clause 64 of these Rules (except for subparagraphs “m”–”p”, “u” and “ch”), and information on whether software using artificial intelligence technologies that is a medical device has a built-in function for the automatic transmission, in accordance with the procedure approved by the registration authority, to the automated information system of the registration authority of information on the data being processed and the results of operation of the software using artificial intelligence technologies that is a medical device, as well as information provided for by the procedure for reporting by entities involved in the circulation of medical devices on all cases of detection of adverse effects;
b) a copy (copies) of the document(s) confirming the powers of the authorized representative of the manufacturer to represent the interests of the manufacturer, bear responsibility with respect to the circulation of the medical device in the territory of the Russian Federation, including with respect to conformity assessment procedures and state registration of the medical device;
c) information on the regulatory documentation for the medical device;
d) the manufacturer’s technical documentation for the medical device;
e) the manufacturer’s operational documentation for the medical device, including the instructions for use or operating manual of the medical device;
f) color photographic images of the general appearance of the medical device, models (brands) of the medical device and accessories necessary for the intended use of the medical device (at least 18 × 24 centimeters in size), as well as images of the labeling and packaging (color layouts of packaging and labels containing the text of the original labeling and additional labeling in Russian applied to medical devices manufactured outside the Russian Federation) (except for software that is a medical device);
g) color photographic images of the electronic medium and software interface (at least 18 × 24 centimeters in size) (for software that is a medical device), as well as images of the labeling and packaging (if any);
h) information on documents confirming the results of technical tests of the medical device issued by the institution, and evidentiary materials of the manufacturer of the medical device (if any);
i) information on documents confirming the results of toxicological studies of the medical device and/or accessories to the medical device that directly or indirectly come into contact with the surface of the human body, its mucous membranes, or internal bodily environments, for which such interaction (contact) is necessary for the performance of their intended functions, issued by the institution, and evidentiary materials of the manufacturer of the medical device (if any);
k) information on documents confirming the results of tests of the medical device for the purpose of type approval of measuring instruments (with respect to medical devices classified as measuring instruments within the sphere of state regulation of ensuring the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation), issued by the institution;
l) documents confirming the results of clinical trials of medical devices issued by medical organizations meeting the requirements approved by the Ministry of Health of the Russian Federation and included in the network of national medical research centers, the composition of which is approved by the Ministry of Health of the Russian Federation, and of software using artificial intelligence technologies intended for processing medical images obtained during radiological examinations, including computed tomography, radiography, fluorography and mammography, provided that the clinical trials are conducted at a clinical center (with respect to clinical trials completed before 1 September 2025), or information on the results of clinical trials of the medical device indicating the number and date of the act of clinical trials of the medical device, as well as the name of the medical organization (with respect to clinical trials completed after 1 September 2025);
m) documents confirming the possibility of carrying out production at the address(es) specified in the registration application as the production site(s) (as applicable): documents confirming the availability of production conditions, and/or copies of certificates of conformity of the quality management system with the requirements of GOST ISO 13485-2017 or ISO 13485:2016, as well as copies of reports on inspections previously conducted for compliance with the said standards (where the said certificates of conformity are submitted), and/or copies of documents confirming the compliance of the quality management system with the requirements for the implementation, maintenance and assessment of the quality management system for medical devices;
n) documents confirming the manufacturer’s right to use the trademark and other means of individualization of the medical device where they are applied to the packaging of the medical device;
o) copies of documents confirming the quality of the medicinal product, pharmaceutical substance, biological material and other substance with which the medical device was manufactured or which are included in its composition and are intended for use only taking into account the intended purpose of the medical device determined by the manufacturer, issued in accordance with the legislation of the country of origin of the medicinal product, pharmaceutical substance, biological material and other substance (except for in vitro diagnostic medical devices);
p) an inventory of the documents, the submission of which is provided for by this Clause, indicating the section IV of these Rules in accordance with which it is planned to undergo the state registration procedure for the domestic medical device;
r) a clinical monitoring plan (for medical devices of potential risk class 3, as well as medical devices implanted in the human body, of potential risk class 26).
102. The requirements specified in Clauses 53, 54 and 56 of these Rules shall not apply to the documents the submission of which is provided for by Clause 101 of these Rules.
103. Within 25 working days from the date of receipt of the documents specified in Clause 101 of these Rules, the institution shall:
a) conduct an examination of the application for conducting an examination of the quality, effectiveness and safety of the medical device and the documents specified in Clause 101 of these Rules, including an assessment of the completeness of the documents and the reliability of the information contained therein, simultaneously with conducting an examination of the completeness and results of tests and studies;
b) prepare an opinion based on the results of the examination of the quality, effectiveness and safety of the medical device;
c) if the opinion based on the results of the examination of the quality, effectiveness and safety of the medical device provided for by subparagraph “b” of this Clause is positive, the institution shall send such opinion to the registration authority.
The opinion based on the results of the examination of the quality, effectiveness and safety of the medical device indicating the possibility of state registration of the domestic medical device shall be accompanied by the documents submitted by the applicant in accordance with Clauses 101 and 104 of these Rules;
d) if the opinion based on the results of the examination of the quality, effectiveness and safety of the medical device is negative, the institution shall notify the applicant of the results of the examination of the quality, effectiveness and safety of the medical device conducted (by registered mail with acknowledgment of receipt or in the form of an electronic document signed with an enhanced qualified electronic signature of an authorized official, by sending it to the applicant’s email address specified in the application for conducting an examination of the quality, effectiveness and safety of the medical device), attaching the opinion based on the results of the examination of the quality, effectiveness and safety of the medical device indicating the impossibility of state registration of the domestic medical device.
104. If the materials and information contained in the documents submitted by the applicant under Clause 101 of these Rules are insufficient for the institution to issue the opinion based on the results of the examination of the quality, effectiveness and safety of the medical device provided for by subparagraph “b” of Clause 103 of these Rules, the institution shall, within 15 working days from the date of receipt of the said documents, send the applicant, by registered mail with acknowledgment of receipt or in the form of an electronic document signed with an enhanced qualified electronic signature of an authorized official, by sending it to the applicant’s email address specified in the application for conducting an examination of the quality, effectiveness and safety of the medical device, a request to provide the necessary information, indicating the nature of the comments and the method for eliminating them.
The said request shall be sent once and shall contain an exhaustive list of all questions and materials necessary for the expert to conduct the examination.
The applicant shall submit a response to the institution’s request within a period not exceeding 35 working days from the date of sending the request. The institution shall prepare an opinion based on the results of the examination of the quality, effectiveness and safety of the medical device within 10 working days from the date of receipt of the applicant’s response to the request.
If the applicant fails to submit a response to the request after 35 working days have elapsed, the institution shall prepare an opinion based on the results of the examination of the quality, effectiveness and safety of the medical device on the basis of the documents at its disposal.
The time from the date of sending the request by the institution until the date of receipt of the response to the request shall not be taken into account when calculating the period for conducting the examination of the quality, effectiveness and safety of the medical device.
105. An opinion based on the results of the examination of the quality, effectiveness and safety of the medical device indicating the impossibility of state registration of the domestic medical device shall be prepared by the institution where the following grounds exist:
a) non-compliance of the medical device with the requirements of the regulatory documentation and the manufacturer’s technical and/or operational documentation;
b) absence of evidence of the quality, and/or effectiveness, and/or safety of the medical device;
c) determination that the risk of harm to the health of citizens and medical workers resulting from the use of the medical device exceeds the effectiveness of its use;
d) the documents specified in Clause 101 of these Rules have not been submitted in full, including under Clause 104 of these Rules, and/or unreliable information has been identified therein, and/or they do not comply with the requirements of Clause 55 of these Rules.
106. Within a period not exceeding 5 working days from the date of receipt of the opinion based on the results of the examination of the quality, effectiveness and safety of the medical device specified in subparagraph “c” of Clause 103 of these Rules, the registration authority shall assess such opinion and take a decision to return the opinion to the institution for revision, the period for which shall not exceed 2 working days from the date of receipt by the institution of the returned opinion, or to accept the opinion based on the results of the examination of the quality, effectiveness and safety of the medical device.
107. Within a period not exceeding 2 working days from the date of receipt of notification of acceptance of the opinion based on the results of the examination of the quality, effectiveness and safety of the medical device, the institution shall notify the applicant (by registered mail with acknowledgment of receipt or in the form of an electronic document signed with an enhanced qualified electronic signature of an authorized official, by sending it to the applicant’s email address specified in the application provided for by subparagraph “a” of Clause 101 of these Rules) of the need to submit, through the unified applicant personal account, to the registration authority, in accordance with the requirements of Clause 53 of these Rules, an application for registration of the domestic medical device drawn up in accordance with Clause 64 of these Rules and additionally containing the details of the opinion based on the results of the examination of the quality, effectiveness and safety of the domestic medical device prepared by the institution.
The period for sending the application for registration of the domestic medical device shall not exceed 30 working days from the date of sending by the institution of the notification provided for by this Clause.
108. Within 5 working days from the date of receipt of the application for registration of the domestic medical device, the registration authority shall verify the completeness and reliability of the information contained therein, including by comparing such information with information submitted by state authorities in accordance with the procedure for interdepartmental information interaction through the system of interdepartmental electronic interaction.
109. Within 5 working days from the date of completion of the verification provided for by Clause 108 of these Rules:
a) where a duly completed application for registration of the domestic medical device has been submitted, the registration authority shall take a decision on the state registration of the medical device, which shall be formalized by an order of the registration authority, inform the applicant of the decision taken by placing the relevant notification in the form of an electronic document signed with an enhanced qualified electronic signature of an authorized official in the unified applicant personal account and the applicant’s electronic account, and enter a registry record in the state register;
b) if unreliable information is indicated in the submitted application for registration of the domestic medical device, or the information provided for by Clause 64 of these Rules has not been submitted in full, the registration authority shall take a decision to terminate further consideration of the application for registration of the domestic medical device and shall inform the applicant thereof by placing the relevant notification, with a reasoned justification of the reasons for taking the said decision, in the form of an electronic document signed with an enhanced qualified electronic signature of an authorized official, in the unified applicant personal account and the applicant’s electronic account.
V. Amendments to the documents contained in the registration dossier that do not require an examination of the quality, efficacy and safety of the medical device
110. The following amendments to the documents contained in the registration dossier require state registration of a new medical device:
a) amendments resulting in changes to the intended purpose and/or operating principle of the medical device;
b) inclusion of information on models (brands) of the registered medical device that do not meet the criteria specified in paragraph 26 of these Rules;
c) amendments resulting in a simultaneous change in the information on the manufacturer and the manufacturing site(s) in relation to the information specified in the registry entry, except for information on the legal form, location address, reorganization, and other information contained in the constituent documents.
111. The following amendments made to the documents contained in the registration dossier do not require an examination of the quality, efficacy and safety of the medical device:
a) changes to the validity periods of the documents contained in the registration dossier (updating of the documents contained in the registration dossier by the applicant);
b) amendments made by a manufacturer of medical devices of potential risk class 1 or non-sterile medical devices of potential risk class 2a that has undergone an assessment of the medical device quality management system, including the processes of design and development of medical devices, in accordance with the requirements for the implementation, maintenance and assessment of the medical device quality management system (except for amendments providing for state registration of a new medical device in accordance with paragraph 110 of these Rules).
If the validity period of the report on the results of inspection of the production of a medical device of potential risk class 1 or a non-sterile medical device of potential risk class 2a has expired, the application for amendments to the documents contained in the registration dossier shall be considered in accordance with the grounds provided for by subparagraphs “a”, “c”–”e” of this paragraph and paragraph 119 of these Rules;
c) changes to information on the manufacturer of the medical device, including information:
on the reorganization of a legal entity;
on changes to the names of the legal entity (full and abbreviated (if any), including the company name), and its location address;
on changes to the surname, first name and patronymic (if any), residential address of an individual registered as an individual entrepreneur, and the details of the identity document;
on changes to the address(es) of the manufacturing site(s) where the change is caused by the renaming of a geographical feature, renaming of a street, square or other territory, or a change in the numbering of addressing objects, including the postal code;
d) changes to information on the authorized representative of the manufacturer, including information:
on the reorganization of a legal entity;
on changes to the name of the legal entity (full and abbreviated (if any), including the company name), and its location address;
on changes to the surname, first name and patronymic (if any), residential address of an individual registered as an individual entrepreneur, and the details of the identity document;
e) change of the name of the medical device with regard to the trademark and other means of individualization;
f) exclusion of information on a model (brand) of the medical device from the registry entry;
g) change in the design of the labeling without changing the symbols used in labeling the medical device;
h) change of the classifier code in the event of the publication of a new edition of the classifier after the decision on state registration of the medical device or amendments to the documents contained in the registration dossier has been adopted.
112. In order to make the amendments specified in paragraph 111 of these Rules to the documents contained in the registration dossier, the applicant shall, no later than 90 business days from the date of the change in the relevant data, submit to the registration authority, through the applicant’s unified personal account:
a) an application for amendments to the documents contained in the registration dossier that do not require an examination of the quality, efficacy and safety of the medical device, containing the information specified in paragraph 64 of these Rules and additionally containing information on the amendments being made, as well as, where applicable, information on the results of clinical trials of the medical device, indicating the number and date of the act on assessment of the results of clinical trials of the medical device, as well as the name of the medical organization;
b) a copy (copies) of the document(s) confirming the authority of the authorized representative of the manufacturer to represent the interests of the manufacturer, to bear responsibility with regard to the circulation of the medical device in the territory of the Russian Federation, including with respect to conformity assessment procedures and state registration of the medical device, as well as to certify the manufacturer’s document(s) that entered into force prior to the execution of the relevant document(s) (the document(s) is/are mandatory for foreign manufacturers; domestic manufacturers shall submit the document(s) if an authorized representative of the manufacturer is present);
c) the documents specified in paragraph 65 of these Rules that have undergone the relevant amendments and demonstrate that making these amendments does not result in changes to the properties and characteristics of the medical device affecting its safety, quality and efficacy, or improves its properties and characteristics while the intended purpose and/or operating principle of the medical device remains unchanged;
d) copies of reports on the results of inspection of production (in the case provided for by subparagraph “b” of paragraph 111 of these Rules):
copies of documents confirming compliance of the quality management system with the requirements for the implementation, maintenance and assessment of the medical device quality management system (in the case of an inspection conducted by an inspecting organization under the jurisdiction (subordination) of the registration authority) (submitted by the applicant on its own initiative);
copies of documents confirming compliance of the quality management system with the requirements for the implementation, maintenance and assessment of the medical device quality management system (submitted in the case of an inspection conducted by an inspecting organization under the jurisdiction (subordination) of a state authority of a member state of the Eurasian Economic Union authorized to carry out and/or coordinate activities in the field of circulation of medical devices in the territory of that state, except for the Russian Federation).
113. The registration authority shall not have the right to require the applicant to indicate in the application for amendments to the documents contained in the registration dossier that do not require an examination of the quality, efficacy and safety of the medical device any information or to submit any documents not provided for by paragraph 112 of these Rules.
The applicant may, on its own initiative, submit other documents substantiating the amendments that do not result in changes to the properties and characteristics of the medical device affecting its safety, quality and efficacy, or improving its properties and characteristics while the intended purpose and/or operating principle of the medical device remains unchanged.
The procedure for making amendments to the documents contained in the registration dossier that do not require an examination of the quality, efficacy and safety of the medical device shall be carried out by the registration authority within a period not exceeding 18 business days from the date of receipt of the application for amendments to the documents contained in the registration dossier that do not require an examination of the quality, efficacy and safety of the medical device and the documents provided for by paragraph 112 of these Rules.
114. Within 5 business days from the date of receipt of the application for amendments to the documents contained in the registration dossier that do not require an examination of the quality, efficacy and safety of the medical device and the documents provided for by paragraph 112 of these Rules, the registration authority shall verify the completeness and accuracy of the information contained therein, including by comparing such information with information submitted by state authorities in the course of interdepartmental information exchange through the system of interdepartmental electronic information exchange.
115. If the application for amendments to the documents contained in the registration dossier that do not require an examination of the quality, efficacy and safety of the medical device has been prepared in violation of the provisions of paragraph 64 and subparagraph “a” of paragraph 112 of these Rules, and/or the submitted documents have been prepared in violation of the provisions of paragraphs 53–55 of these Rules, and/or inaccurate information is specified in the application for amendments to the documents contained in the registration dossier that do not require an examination of the quality, efficacy and safety of the medical device and in the submitted documents, and/or the documents provided for by paragraph 112 of these Rules have not been submitted in full, the registration authority shall notify the applicant of the need to remedy the identified violations and/or submit the missing documents within 30 business days from the date of placement of such notification, in the form of an electronic document signed with an enhanced qualified electronic signature of an authorized official, in the applicant’s unified personal account and the applicant’s electronic account. The applicant shall remedy the identified violations and/or submit the missing documents through the applicant’s unified personal account.
The period from the date of notification of the applicant by the registration authority until the date of receipt of the response to the notification or notification of failure to provide a response to the request shall not be taken into account when calculating the period of the procedure for making amendments to the documents contained in the registration dossier.
116. If the identified violations have not been remedied and/or the missing documents have not been submitted within a period not exceeding 30 business days, including taking into account the provision of paragraph 53 of these Rules, the registration authority shall decide to terminate further consideration of the application for amendments to the documents contained in the registration dossier that do not require an examination of the quality, efficacy and safety of the medical device, with a reasoned justification of the reasons for adopting the said decision.
117. Within 3 business days from the date of completion of the verification provided for by paragraph 114 of these Rules (in the case of submission of a duly prepared application for amendments to the documents contained in the registration dossier that do not require an examination of the quality, efficacy and safety of the medical device and all documents provided for by paragraph 112 of these Rules), as well as in the event that the identified violations are remedied and/or the documents provided for by paragraph 112 of these Rules are submitted within a period not exceeding 30 business days, the registration authority shall decide to commence the procedure for making amendments to the documents contained in the registration dossier.
118. Within a period not exceeding 10 business days from the date of the decision to commence the procedure for making amendments to the documents contained in the registration dossier, the registration authority shall carry out the following measures:
a) adopt a decision to make amendments to the documents contained in the registration dossier, which shall be formalized by an order of the registration authority, and inform the applicant of the decision adopted by placing the corresponding notification in the form of an electronic document signed with an enhanced qualified electronic signature of an authorized official in the applicant’s unified personal account and the applicant’s electronic account;
b) make the amendments to the registry entry.
VI. Amendments to the Documents Contained in the Registration Dossier Requiring an Examination of the Quality, Effectiveness and Safety of the Medical Device
119. Amendments to the documents contained in the registration dossier, except for the cases specified in paragraph 111 of these Rules, shall be made based on the results of an examination of the quality, effectiveness and safety of the medical device.
120. To make the amendments to the documents contained in the registration dossier specified in paragraph 119 of these Rules, the applicant shall, no later than 90 working days from the date of amendment of the relevant data, submit to the registration authority, through the applicant’s unified personal account:
a) an application for making amendments to the documents contained in the registration dossier requiring an examination of the quality, effectiveness and safety of the medical device, containing the information specified in paragraph 64 of these Rules and additionally containing information on the amendments being made, as well as, where applicable, information on the results of clinical trials of the medical device, indicating the number and date of the act on assessment of the results of clinical trials of the medical device and the name of the medical organization;
b) a copy (copies) of the document(s) confirming the powers of the authorized representative of the manufacturer (producer) to represent the interests of the manufacturer (producer), to bear responsibility with regard to the circulation of the medical device in the territory of the Russian Federation, including with regard to conformity assessment procedures and state registration, as well as to certify the document(s) of the manufacturer (producer) that entered into force prior to the execution of the relevant documents (the document(s) shall be mandatory for foreign manufacturers (producers); domestic manufacturers (producers) shall submit such document(s) if an authorized representative of the manufacturer (producer) is present);
c) documents confirming the possibility of carrying out production at the address(es) specified in the registration application as the production site(s), where applicable: documents confirming the availability of production conditions, and/or copies of certificates of conformity of the quality management system with the requirements of GOST ISO 13485-2017 or ISO 13485:2016, as well as copies of reports on inspections previously conducted for compliance with the specified standards (if the specified certificates of conformity are submitted), and/or copies of documents confirming the conformity of the quality management system with the requirements for the implementation, maintenance and assessment of the quality management system for medical devices (submitted where an inspection is conducted by an inspecting organization under the authority (subordination) of a state authority of a Member State of the Eurasian Economic Union authorized to carry out and/or coordinate activities in the sphere of circulation of medical devices in the territory of that state, with the exception of the Russian Federation);
d) the documents specified in paragraph 65 of these Rules that have undergone the relevant amendments and demonstrate that making such amendments does not entail changes in the properties and characteristics of the medical device affecting its safety, quality and effectiveness, or improves its properties and characteristics while the intended purpose and/or principle of operation of the medical device remains unchanged.
The applicant shall have the right, on its own initiative, to submit other documents substantiating amendments that do not entail changes in the properties and characteristics of the medical device affecting its safety, quality and effectiveness, or that improve its properties and characteristics while the intended purpose and/or principle of operation of the medical device remains unchanged.
121. The registration authority shall not have the right to require the applicant to indicate in the application for making amendments to the documents contained in the registration dossier requiring an examination of the quality, effectiveness and safety of the medical device information or to submit documents not provided for by paragraph 120 of these Rules.
122. Within 5 working days from the date of receipt of the application for making amendments to the documents contained in the registration dossier requiring an examination of the quality, effectiveness and safety of the medical device and the documents provided for by paragraph 120 of these Rules, the registration authority shall verify the completeness and reliability of the information contained therein, including by comparing such information with information submitted by state authorities through interdepartmental information exchange using the system of interdepartmental electronic interaction.
123. If the application for making amendments to the documents contained in the registration dossier requiring an examination of the quality, effectiveness and safety of the medical device has been executed in violation of the provisions of paragraph 64 and subparagraph “a” of paragraph 120 of these Rules, and/or the submitted documents have been executed in violation of the provisions of paragraphs 53–55 of these Rules, and/or the application for making amendments to the documents contained in the registration dossier requiring an examination of the quality, effectiveness and safety of the medical device and the submitted documents contain inaccurate information, and/or the documents provided for by paragraph 120 of these Rules have not been submitted in full, the registration authority shall notify the applicant of the need to remedy the identified violations and/or submit the missing documents within 30 working days from the date of placement of such notification, in the form of an electronic document signed with an enhanced qualified electronic signature of an authorized official, in the applicant’s unified personal account and the applicant’s electronic account. The applicant shall remedy the identified violations and/or submit the missing documents through the applicant’s unified personal account.
The time from the date of notification by the registration authority of the applicant until the date of receipt of a response to the notification or notification of failure to submit a response to the request shall not be taken into account when calculating the period of the procedure for making amendments to the documents contained in the registration dossier.
124. Within 3 working days from the date of completion of the verification provided for by paragraph 90 of these Rules (in the case of submission of a duly executed application for making amendments to the documents contained in the registration dossier requiring an examination of the quality, effectiveness and safety of the medical device and the documents provided for by paragraph 120 of these Rules in full), as well as in the event that the identified violations are remedied and/or the documents provided for by paragraph 120 of these Rules are submitted within a period not exceeding 30 working days, the registration authority shall make a decision to commence the procedure for making amendments to the documents contained in the registration dossier.
125. If, within a period not exceeding 30 working days, the identified violations have not been remedied and/or the missing documents have not been submitted, including taking into account the provision of paragraph 53 of these Rules, the registration authority shall make a decision to terminate further consideration of the application for making amendments to the documents contained in the registration dossier requiring an examination of the quality, effectiveness and safety of the medical device and the documents provided for by paragraph 120 of these Rules, and shall inform the applicant thereof by placing the relevant notification, with a reasoned justification of the grounds for adopting such decision, in the form of an electronic document signed with an enhanced qualified electronic signature of an authorized official, in the applicant’s unified personal account and the applicant’s electronic account.
126. Amendments to the documents contained in the registration dossier requiring an examination of the quality, effectiveness and safety of the medical device shall be made by the registration authority within a period not exceeding 36 working days from the date of receipt of the application for making amendments to the documents contained in the registration dossier requiring an examination of the quality, effectiveness and safety of the medical device and the documents provided for by paragraph 120 of these Rules.
127. Within 3 working days from the date of making the decision to commence the procedure for making amendments to the documents contained in the registration dossier, the registration authority shall prepare and issue an assignment for conducting the examination to the expert institution.
128. The examination of the application for making amendments to the documents contained in the registration dossier requiring an examination of the quality, effectiveness and safety of the medical device and of the documents specified in paragraph 120 of these Rules shall be conducted simultaneously with the examination of the completeness and results of tests and studies within a period not exceeding 15 working days from the date of receipt by the expert institution of the corresponding assignment from the registration authority.
129. When conducting an examination of the quality, effectiveness and safety of the medical device, the expert institution shall not be permitted to request from the applicant or other persons the materials necessary for conducting the examination.
If the materials and information contained in the application submitted by the applicant for making amendments to the documents contained in the registration dossier requiring an examination of the quality, effectiveness and safety of the medical device and in the documents provided for by paragraph 120 of these Rules are insufficient for the expert to issue a conclusion, the expert shall raise the issue of providing the necessary materials and information with the head of the expert institution, who shall submit the relevant request to the registration authority that issued the assignment for conducting the examination. The said request shall contain an exhaustive list of all issues, materials and information necessary for the expert to conduct the examination.
Within 2 working days from the date of receipt of the request from the head of the expert institution, the registration authority shall send the applicant a request to provide the necessary information, indicating the nature of the comments and the method for remedying them. The said request shall be sent once in the form of an electronic document signed with an enhanced qualified electronic signature of an authorized official by placing it in the applicant’s electronic account and the applicant’s unified personal account.
The applicant shall provide a response to the request of the registration authority through the applicant’s unified personal account within a period not exceeding 50 working days from the date of sending this request. Within 2 working days from the date of receipt of the applicant’s response to the request, the registration authority shall forward such response to the expert institution. If, upon expiry of 50 working days, the applicant has failed to provide a response to the request, the registration authority shall, within 2 working days, send the expert institution a notification of the applicant’s failure to provide a response to the request of the registration authority for preparation of a conclusion on the possibility (impossibility) of making amendments to the documents contained in the registration dossier, the form of which is approved by the Ministry of Health of the Russian Federation (hereinafter referred to as the “conclusion on making amendments to the documents contained in the registration dossier”), on the basis of the documents available to it.
The time from the date of sending the request of the registration authority until the date of receipt of the response to the request or notification of failure to provide a response to the request shall not be taken into account when calculating the period for conducting the examination of the quality, effectiveness and safety of the medical device.
If the registration authority identifies inaccurate and/or insufficient information or documents in the documents submitted by the applicant in response to the request and/or non-compliance of the format of the submitted documents with the provisions of paragraphs 53–55 of these Rules, the registration authority shall, within 2 working days, send the applicant, in the form of an electronic document signed with an enhanced qualified electronic signature of an authorized official, by placing it in the applicant’s unified personal account and the applicant’s electronic account, a reasoned decision on the possibility of the applicant repeatedly submitting amended documents before expiry of 50 working days from the date of sending the request. If the applicant fails to submit the requested documents and information within the specified period, the examination of the quality, effectiveness and safety of the medical device shall continue on the basis of the documents previously submitted by the applicant and the information contained in the registration dossier available to the expert institution.
130. Within a period not exceeding 15 working days from the date of receipt of the documents specified in paragraph 120 of these Rules, the expert institution shall conduct the examination provided for by paragraph 127 of these Rules and shall send to the registration authority a conclusion on making amendments to the documents contained in the registration dossier.
131. The grounds for the expert institution to issue a conclusion on making amendments to the documents contained in the registration dossier certifying the impossibility of making amendments to the documents contained in the registration dossier shall be:
a) unreliability of the submitted information substantiating the making of amendments, including information identified by the registration authority as a result of state control (supervision) over the circulation of medical devices;
b) absence in the documents submitted by the applicant of information confirming that the amendments made to the documents contained in the registration dossier do not entail changes in the properties and characteristics affecting the quality, effectiveness and safety of the medical device, or improve the properties and characteristics while the intended purpose and/or principle of operation of the medical device remains unchanged;
c) absence of information confirming the unchanged intended purpose and/or principle of operation of the medical device in connection with the amendments being made to the documentation;
d) the need to conduct state registration of a new medical device in accordance with paragraph 110 of these Rules;
e) presence of inaccurate information in the documents contained in the registration dossier.
132. Within a period not exceeding 10 working days from the date of receipt of the conclusion on making amendments to the documents contained in the registration dossier, the registration authority shall carry out the following measures:
a) assessment of the conclusion on making amendments to the documents contained in the registration dossier for the purpose of determining its compliance with the assignment for conducting the examination. If the conclusion on making amendments to the documents contained in the registration dossier is found not to comply with the said assignment, such conclusion shall be returned to the expert institution for revision, the period for which shall not exceed 2 working days from the date of receipt by the expert institution of the returned conclusion;
b) in the event of receipt of the conclusion on making amendments to the documents contained in the registration dossier provided for by paragraph 131 of these Rules, no later than the next working day after assessment of such conclusion for the purpose of determining its compliance with the assignment for conducting the examination, the registration authority shall place an electronic image of this conclusion in the applicant’s electronic account and send the relevant information to the applicant’s unified personal account.
Within 10 working days from the date of placement in the applicant’s electronic account of the conclusion on making amendments to the documents contained in the registration dossier specified in paragraph 131 of these Rules, the applicant shall have the right to familiarize itself with the conclusion on making amendments to the documents contained in the registration dossier and, if it has objections, submit objections through the applicant’s electronic account.
If, through the applicant’s electronic account, the applicant’s objections to the conclusion on making amendments to the documents contained in the registration dossier provided for by paragraph 131 of these Rules are received within a period not exceeding 10 working days, the registration authority shall, within 30 working days from the date of receipt of the objections, consider them with the involvement of the expert institution that issued such conclusion. If the applicant’s objections are not received within the established period, the registration authority shall carry out the measures provided for by subparagraphs “c” and “d” of this paragraph. When considering the objections, the registration authority shall, if necessary to provide explanations, involve the applicant.
Following consideration of the objections, a decision shall be made to recognize the objections as fully or partially justified, which shall be formalized by a letter of the registration authority and sent to the expert institution together with the conclusion on making amendments to the documents contained in the registration dossier provided for by paragraph 131 of these Rules for revision, the period for which shall not exceed 5 working days from the date of receipt by the expert institution of the returned conclusion on making amendments to the documents contained in the registration dossier, or to recognize the objections as completely unjustified.
The time from the date of placement by the registration authority in the applicant’s electronic account of the conclusion on making amendments to the documents contained in the registration dossier specified in paragraph 131 of these Rules until the decision following consideration of the objections is made shall not be taken into account when calculating the period for conducting the examination of the quality, effectiveness and safety of the medical device;
c) making a decision on the possibility (impossibility) of making amendments to the documents contained in the registration dossier, which shall be formalized by an order of the registration authority, and informing the applicant of the decision made by sending the relevant notification in the form of an electronic document signed with an enhanced qualified electronic signature of an authorized official, or by placing it in the applicant’s unified personal account and the applicant’s electronic account;
d) making amendments to the register entry (in the event of a decision being made on the possibility of making amendments to the documents contained in the registration dossier).
133. The grounds for making a decision to refuse to make amendments to the documents contained in the registration dossier shall be:
a) receipt by the registration authority from the expert institution of a conclusion on making amendments to the documents contained in the registration dossier certifying the impossibility of making amendments to the documents contained in the registration dossier and/or the registration authority’s decision to recognize the applicant’s objections as completely or partially unjustified;
b) identification by the registration authority, based on the results of federal state control (supervision) over the circulation of medical devices, of discrepancies between the data on the effectiveness and safety of the medical device and the data on the medical device contained in the application for making amendments to the documents contained in the registration dossier requiring an examination of the quality, effectiveness and safety of the medical device and in the documents specified in paragraph 120 of these Rules.
VII. Specific Features of Amendments to Documents Contained in the Registration Dossier for Software Using Artificial Intelligence Technologies That Is a Medical Device
134. Amendments to documents contained in the registration dossier for software using artificial intelligence technologies that is a medical device:
a) in the absence, in the software using artificial intelligence technologies that is a medical device, of a built-in function for automatic transmission, in the manner approved by the registration authority, to the automated information system of the registration authority of information on the data being processed, the results of operation of the software using artificial intelligence technologies that is a medical device, as well as information provided for by the procedure for reporting by entities involved in the circulation of medical devices on all cases of detection of adverse effects, shall be carried out in accordance with paragraphs 110–133 of these Rules (as applicable);
b) with regard to amendments to the version numbering that do not affect the intended purpose and/or operating principle of the software using artificial intelligence technologies that is a medical device, where such software has a built-in function for automatic transmission, in the manner approved by the registration authority, to the automated information system of the registration authority of information on the data being processed, the results of operation of the said software, as well as information provided for by the procedure for reporting by entities involved in the circulation of medical devices on all cases of detection of adverse effects, shall be carried out in accordance with paragraphs 119–133 or 135 and 136 of these Rules.
135. For making amendments to documents contained in the registration dossier for software using artificial intelligence technologies that is a medical device, with regard to amendments to its version numbering that do not affect its intended purpose and/or operating principle, the applicant shall submit to the registration authority, through the applicant’s unified personal account, an application for making amendments to documents contained in the registration dossier for software using artificial intelligence technologies that is a medical device, specifying the following information:
a) name of the medical device;
b) information on the registration number and date of state registration of the medical device (making amendments to documents contained in the registration dossier);
c) with regard to the applicant — full and abbreviated names (if any), legal form, taxpayer identification number (if any), location address — for a legal entity, or surname, first name and patronymic (if any), details of the identity document, taxpayer identification number (if any), residential address — for an individual registered as an individual entrepreneur, as well as telephone number and email address of the legal entity or individual registered as an individual entrepreneur;
d) information on the version of the software using artificial intelligence technologies that is a medical device, information on which is to be entered in the state register;
e) information making it possible to identify the results of clinical trials of the software using artificial intelligence technologies that is a medical device (specifying the number and date of the clinical trial report for the medical device, as well as the name of the medical organization);
f) information on payment of the state duty (date and number of the payment order);
g) information on the applicant’s liability for the accuracy and identity of the information contained in the registration dossier and the application for making amendments to documents contained in the registration dossier for software using artificial intelligence technologies that is a medical device.
136. Within 5 working days from the date of receipt of the application for making amendments to documents contained in the registration dossier for software using artificial intelligence technologies that is a medical device, the registration authority shall verify the completeness and accuracy of the information contained therein, including by comparing such information with information submitted by state authorities in the procedure of interdepartmental information interaction through the system of interdepartmental electronic interaction. Within 5 working days from the date of completion of the said verification:
a) in the event that a duly completed application for making amendments to documents contained in the registration dossier for software using artificial intelligence technologies that is a medical device is submitted, the registration authority shall make a decision on making amendments to the documents contained in the registration dossier, which shall be formalized by an order of the registration authority, inform the applicant of the decision made by placing the relevant notification in the form of an electronic document signed with an enhanced qualified electronic signature of an authorized official in the applicant’s unified personal account and the applicant’s electronic account, and shall also make amendments to the registry entry;
b) in the event that the application for making amendments to documents contained in the registration dossier for software using artificial intelligence technologies that is a medical device contains inaccurate information or the information provided for by paragraph 135 of these Rules is not submitted in full, the registration authority shall make a decision to terminate further consideration of the application for making amendments to documents contained in the registration dossier for software using artificial intelligence technologies that is a medical device and shall inform the applicant thereof by placing the relevant notification, with a reasoned justification of the reasons for making the said decision, in the form of an electronic document signed with an enhanced qualified electronic signature of an authorized official in the applicant’s unified personal account and the applicant’s electronic account.
VIII. Cancellation of State Registration of a Medical Device
137. The registration authority shall make a decision to cancel the state registration of a medical device in the following cases:
a) submission by the applicant, through the applicant’s unified personal account, of an application for cancellation of the state registration of the medical device containing information in accordance with paragraph 138 of these Rules;
b) issuance by a court of a decision on infringement of the rights of the right holder to the results of intellectual activity and means of individualization equivalent thereto in the circulation of medical devices (or their models (brands));
c) submission by the federal executive body authorized by the Government of the Russian Federation, based on the results of the federal state control (supervision) over the circulation of medical devices carried out by it, of information confirming facts and circumstances creating a threat to the life and health of citizens and medical workers in the use and operation of medical devices;
d) identification by the registration authority, based on the results of federal state control (supervision) over the circulation of medical devices, of the inaccuracy of information in the documents contained in the registration dossier submitted by the applicant and affecting the results of the examination of the quality, efficacy and safety of the medical device;
e) receipt by the registration authority of an opinion of the expert institution stating that the instrument, apparatus, device, equipment, material and other products contained in the state register, by their intended purpose and/or operating principle, cannot be used for medical purposes and/or are not medical devices. The opinion of the expert institution stating that the instrument, apparatus, device, equipment, material and other products contained in the state register, by their intended purpose and/or operating principle, cannot be used for medical purposes and/or are not medical devices shall be submitted (sent) by the expert institution to the registration authority within 10 working days from the date of receipt by the expert institution of the relevant assignment from the registration authority, with the documents contained in the registration dossier attached.
In the event that the registration authority receives an opinion of the expert institution stating that the instrument, apparatus, device, equipment, material and other products may be used for medical purposes and/or be a medical device after amendments have been made to the documents contained in the registration dossier, and/or that the decision on the impossibility of using the instrument, apparatus, device, equipment, material and other products for medical purposes and/or the impossibility of classifying them as medical devices applies not to all registered models (brands) of the medical device, the registration authority, prior to making a decision to cancel the state registration of the medical device:
shall notify the applicant, by placing the relevant notification in the form of an electronic document signed with an enhanced qualified electronic signature of an authorized official in the applicant’s electronic account, with the opinion of the expert institution attached stating that the instrument, apparatus, device, equipment, material and other products contained in the state register, by their intended purpose and/or operating principle, cannot be used for medical purposes and/or are not medical devices, of the need to make amendments to the documents contained in the registration dossier within a period not exceeding 180 working days from the date of sending the said notification;
shall make a decision to suspend the validity of the state registration of the medical device for 180 working days from the date of sending the notification of the need to make amendments to the documents contained in the registration dossier;
Subparagraph “e” of paragraph 137 shall be effective from 01.09.2027 (first paragraph of paragraph 7).
f) failure to make amendments to the documents contained in the registration dossier confirming the authority of the authorized representative of the manufacturer (producer) to represent the interests of the manufacturer (producer) and bear responsibility with regard to the circulation of the medical device in the territory of the Russian Federation, including on matters concerning conformity assessment procedures and state registration, provided for by subparagraph “a” or “d” of paragraph 111 of these Rules, within a period not exceeding 90 working days from the date of expiry of the relevant document, or failure to include in the registration dossier information on the appointment of an authorized representative of the manufacturer (producer) within a period not exceeding 90 working days from the date of entry into force of the requirements provided for by the second paragraph of paragraph 29 of these Rules.
Prior to making a decision to cancel the state registration of the medical device in the case provided for by the first paragraph of this subparagraph, the registration authority shall make a decision to suspend the validity of the state registration of the medical device for 90 working days from the date of expiry of the document confirming the authority of the authorized representative of the manufacturer (producer) to represent the interests of the manufacturer (producer) and bear responsibility with regard to the circulation of the medical device in the territory of the Russian Federation, including on matters concerning conformity assessment procedures and state registration, or from the date of expiry of the period provided for by the second paragraph of paragraph 29 of these Rules, with simultaneous notification thereof to all participants in the sphere of circulation of medical devices by means of an information letter posted on the official website of the registration authority on the Internet, as well as through the applicant’s electronic account or by sending the manufacturer (producer) of the medical device a notification of the need to update the information on the authorized representative of the manufacturer (producer);
g) absence in the register of conclusions of compliance with the requirements for implementation, maintenance and assessment of the quality management system for medical devices of information on a periodic (scheduled) inspection conducted, or failure to make amendments to the documents contained in the registration dossier in accordance with subparagraph “a” of paragraph 111 of these Rules within a period not exceeding 90 working days from the date of expiry of the validity period of the inspection report (for medical devices that have undergone an initial production inspection, with the exception of medical devices of potential risk class 1 and non-sterile medical devices of potential risk class 2a).
Prior to making a decision to cancel the state registration of the medical device in the case provided for by the first paragraph of this subparagraph, the registration authority shall make a decision to suspend the validity of the state registration of the medical device for 180 working days from the date of expiry of the validity period of the inspection report or from the date of issuance of a negative conclusion based on the results of a periodic (scheduled) or unscheduled inspection, with simultaneous notification thereof to all participants in the sphere of circulation of medical devices by means of an information letter posted on the official website of the registration authority on the Internet, as well as through the applicant’s personal account or by sending the manufacturer (producer) and the authorized representative of the manufacturer (producer) of the medical device a notification of the need to conduct a periodic (scheduled) or unscheduled inspection;
h) identification by the registration authority of the fact that amendments have been made to the documents contained in the registration dossier for software using artificial intelligence technologies that is a medical device for reasons other than those provided for by paragraph 135 of these Rules;
i) failure to submit to the registration authority a report on clinical monitoring of the medical device in accordance with the procedure for reporting by entities involved in the circulation of medical devices on all cases of detection of adverse effects.
Prior to making a decision to cancel the state registration of the medical device in the case provided for by the first paragraph of this subparagraph, the registration authority shall make a decision to suspend the validity of the state registration of the medical device for 30 working days from the date established by the procedure for reporting by entities involved in the circulation of medical devices on all cases of detection of adverse effects, with simultaneous notification thereof to all participants in the sphere of circulation of medical devices by means of an information letter posted on the official website of the registration authority on the Internet, as well as through the applicant’s electronic account or by sending the applicant a notification of the need to submit a report on clinical monitoring of the medical device;
j) identification by the registration authority of inaccurate information in the documents submitted by the applicant within the framework of the state registration procedure for the medical device;
k) classification of a previously registered medical device as one of the medical devices provided for by paragraph 5 of Part 5 of Article 38 of the Federal Law “On the Fundamentals of Health Protection of Citizens in the Russian Federation.”
138. The following information shall be specified in the application for cancellation of the state registration of a medical device provided for by subparagraph “a” of paragraph 137 of these Rules:
a) name of the medical device (specifying the models (brands) of the medical device, their composition and accessories necessary for the intended use of the medical device or its models (brands) (if any));
b) with regard to the manufacturer (producer) of the medical device — full and abbreviated names (if any) (with transliteration), legal form, taxpayer identification number (if any), location address — for a legal entity, or surname, first name and patronymic (if any), details of the identity document, taxpayer identification number (if any), residential address — for an individual registered as an individual entrepreneur, as well as telephone number and email address of the legal entity or individual registered as an individual entrepreneur;
c) with regard to the authorized representative of the manufacturer (producer) — full and abbreviated names (if any), legal form, taxpayer identification number, location address — for a legal entity, or surname, first name and patronymic (if any), details of the identity document, taxpayer identification number, residential address — for an individual registered as an individual entrepreneur, as well as telephone number and email address of the legal entity or individual registered as an individual entrepreneur;
d) date of state registration of the medical device (making amendments to documents contained in the registration dossier) and its registration number;
e) information on the reasons for submitting the application for cancellation of the state registration of the medical device;
f) information on the applicant’s liability for the accuracy and identity of the information contained in the submitted documents and the application for cancellation of the state registration of the medical device.
139. The application for cancellation of the state registration of a medical device provided for by subparagraph “a” of paragraph 137 of these Rules may be submitted by the authorized representative of the manufacturer (producer) provided that the following conditions are simultaneously met:
a) an up-to-date document confirming the authority of the authorized representative of the manufacturer (producer) to represent the interests of the manufacturer (producer), bear responsibility with regard to the circulation of the medical device in the territory of the Russian Federation, including on matters concerning conformity assessment procedures and state registration, as well as to certify documents of the manufacturer (producer), which entered into force prior to the preparation of the relevant documents, is available in the registration dossier, or such document is submitted to the registration authority in accordance with the requirements of paragraph 53 of these Rules together with the application for cancellation of the state registration of the medical device;
b) the following documents are submitted to the registration authority together with the application for cancellation of the state registration of the medical device:
a letter from the manufacturer (producer) confirming its intention to cancel the state registration of the medical device (in the event that the application for cancellation of the state registration of the medical device is submitted by the authorized representative of the manufacturer (producer));
a copy (copies) of the document(s) confirming the authority of the authorized representative of the manufacturer (producer) to represent the interests of the manufacturer (producer), bear responsibility with regard to the circulation of the medical device in the territory of the Russian Federation, including on matters concerning conformity assessment procedures and state registration of the medical device, as well as to certify document(s) of the manufacturer (producer), which entered into force prior to the preparation of the relevant documents (in the absence of an up-to-date document in the registration dossier) (the document(s) shall be mandatory for foreign manufacturers (producers); domestic manufacturers (producers) shall submit it (them) if there is an authorized representative of the manufacturer (producer).
140. In the event that the application for cancellation of the state registration of the medical device is submitted in violation of the requirements of paragraph 139 of these Rules, and/or the submitted documents are prepared in violation of the provisions of paragraphs 53–55 of these Rules, and/or inaccurate information is specified in the application for cancellation of the state registration of the medical device and the submitted documents, and/or the documents provided for by paragraph 139 of these Rules are not submitted in full, the registration authority shall, within 7 working days from the date of receipt of such application and documents, make a decision to terminate further consideration of the said application, with a reasoned justification of the reasons for making such decision.
141. Within 7 working days from the date of occurrence of one of the cases specified in paragraph 137 of these Rules, the registration authority shall:
a) make a decision to cancel the state registration of the medical device;
b) make an entry on cancellation of the state registration in the state register;
c) inform the applicant of the cancellation of the state registration of the medical device by placing the relevant notification in the form of an electronic document signed with an enhanced qualified electronic signature of an authorized official in the applicant’s unified personal account and the applicant’s electronic account.
Appendix
to the Rules for
State Registration of Medical Devices
(form)
MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION
ETHICS COUNCIL
Date of the Ethics Council meeting “” __________ 20
CONCLUSION ON THE ETHICAL JUSTIFICATION FOR CONDUCTING CLINICAL TRIALS OF A MEDICAL DEVICE
No. ______ dated “” __________ 20
1. Name of the medical device (including accessories necessary for the intended use of the medical device)
2. Manufacturer of the medical device
(full and abbreviated name (if any)
legal form of the legal entity, address of its registered office, or full name, address of residence for an individual registered as a sole proprietor)
3. Applicant
4. Decision:
(information on the ethical justification for conducting
clinical trials of the medical device, reasons
for the decision regarding the impossibility of conducting
clinical trials of the medical device)
Chairman of the Council
(Full name) (signature)
Experts
(Full name) (signature)
Appendix
to the Resolution of the Government
of the Russian Federation
dated November 30, 2024 No. 1684
LIST OF ACTS OF THE GOVERNMENT OF THE RUSSIAN FEDERATION THAT HAVE BECOME INVALID
1. Resolution of the Government of the Russian Federation [dated December 27, 2012 No. 1416] “On Approval of the Rules for State Registration of Medical Devices” (Collected Legislation of the Russian Federation, 2013, No. 1, Article 14).
2. Resolution of the Government of the Russian Federation [dated October 17, 2013 No. 930] “On Amendments to the Resolution of the Government of the Russian Federation dated December 27, 2012 No. 1416” (Collected Legislation of the Russian Federation, 2013, No. 43, Article 5556).
3. Resolution of the Government of the Russian Federation [dated July 17, 2014 No. 670] “On Amendments to the Rules for State Registration of Medical Devices” (Collected Legislation of the Russian Federation, 2014, No. 30, Article 4310).
4. Resolution of the Government of the Russian Federation [dated February 10, 2017 No. 160] “On Amendments to the Resolution of the Government of the Russian Federation dated December 27, 2012 No. 1416” (Collected Legislation of the Russian Federation, 2017, No. 8, Article 1233).
5. Resolution of the Government of the Russian Federation [dated May 31, 2018 No. 633] “On Amendments to the Rules for State Registration of Medical Devices” (Collected Legislation of the Russian Federation, 2018, No. 24, Article 3523).
6. Resolution of the Government of the Russian Federation [dated March 18, 2020 No. 299] “On Amendments to the Rules for State Registration of Medical Devices” (Collected Legislation of the Russian Federation, 2020, No. 12, Article 1792).
7. Resolution of the Government of the Russian Federation [dated September 1, 2020 No. 1335] “On Amendment to Paragraph 2 of the Rules for State Registration of Medical Devices” (Collected Legislation of the Russian Federation, 2020, No. 36, Article 5637).
8. Resolution of the Government of the Russian Federation [dated November 24, 2020 No. 1906] “On Amendments to the Rules for State Registration of Medical Devices” (Collected Legislation of the Russian Federation, 2020, No. 49, Article 7897).
APPROVED
by the Resolution of the Government
of the Russian Federation
dated November 30, 2024 No. 1684
AMENDMENTS TO BE MADE TO THE ACTS OF THE GOVERNMENT OF THE RUSSIAN FEDERATION
(as amended by Resolution of the Government of the Russian Federation [dated October 27, 2025 No. 1670])
1. In the Resolution of the Government of the Russian Federation [dated December 31, 2020 No. 2467] “On Approval of the List of Regulatory Legal Acts and Groups of Regulatory Legal Acts of the Government of the Russian Federation, Regulatory Legal Acts, Certain Provisions of Regulatory Legal Acts and Groups of Regulatory Legal Acts of Federal Executive Bodies, Legal Acts, Certain Provisions of Legal Acts, Groups of Legal Acts of Executive and Administrative Bodies of State Power of the RSFSR and the USSR, Decisions of the State Commission on Radio Frequencies Containing Mandatory Requirements in Respect of Which the Provisions of Parts 1, 2 and 3 of Article 15 of the Federal Law ‘On Mandatory Requirements in the Russian Federation’ Do Not Apply” (Collected Legislation of the Russian Federation, 2021, No. 2, Article 471; 2022, No. 23, Article 3785; 2024, No. 25, Article 3505; No. 33, Article 5163; No. 38, Article 5651; No. 40, Article 5981; No. 42, Article 6257; No. 44, Article 6619):
a) the subparagraph has become invalid; (as amended by Resolution of the Government of the Russian Federation [dated October 27, 2025 No. 1670]);
b) in the list of regulatory legal acts and groups of regulatory legal acts of the Government of the Russian Federation, regulatory legal acts, certain provisions of regulatory legal acts and groups of regulatory legal acts of federal executive bodies, legal acts, certain provisions of legal acts, groups of legal acts of executive and administrative bodies of state power of the RSFSR and the USSR, decisions of the State Commission on Radio Frequencies containing mandatory requirements in respect of which the provisions of Parts 1, 2 and 3 of Article 15 of the Federal Law “On Mandatory Requirements in the Russian Federation” do not apply, [item 637] shall be deleted.
2. In the second paragraph of [item 6] of the amendments made to the Resolution of the Government of the Russian Federation dated December 31, 2020 No. 2467, approved by Resolution of the Government of the Russian Federation dated June 12, 2024 No. 792 “On Amendments to Certain Acts of the Government of the Russian Federation” (Collected Legislation of the Russian Federation, 2024, No. 25, Article 3505), the figures “637,” shall be deleted.