{"id":2393,"date":"2026-08-19T15:36:28","date_gmt":"2026-08-19T12:36:28","guid":{"rendered":"https:\/\/grandlocus.com\/?post_type=resources&p=2393"},"modified":"2026-09-01T13:03:05","modified_gmt":"2026-09-01T10:03:05","slug":"government-of-the-russian-federation-resolution-no-552","status":"publish","type":"resources","link":"https:\/\/grandlocus.com\/en\/resources\/government-of-the-russian-federation-resolution-no-552\/","title":{"rendered":"Decree No. 552 dated 01 April, 2022 of the Government of the Russian Federation"},"content":{"rendered":"

GOVERNMENT OF THE RUSSIAN FEDERATION<\/strong>
\nRESOLUTION<\/strong><\/p>\n

dated April 1, 2022 No. 552<\/strong><\/p>\n

 <\/p>\n

ON APPROVAL OF THE SPECIFIC FEATURES OF THE CIRCULATION, INCLUDING THE SPECIFIC FEATURES OF STATE REGISTRATION, OF MEDICAL DEVICES IN THE EVENT OF THEIR SHORTAGE OR THE RISK OF A SHORTAGE ARISING IN CONNECTION WITH THE INTRODUCTION OF ECONOMIC RESTRICTIVE MEASURES AGAINST THE RUSSIAN FEDERATION<\/strong><\/p>\n

Pursuant to Part 5.1 of Article 38 of the Federal Law \u201cOn the Fundamentals of Health Protection of Citizens in the Russian Federation\u201d, and Paragraph 3 of Part 1 of Article 18 of Federal Law No. 46-FZ dated March 8, 2022, \u201cOn Amendments to Certain Legislative Acts of the Russian Federation,\u201d the Government of the Russian Federation hereby resolves:<\/p>\n

1. To approve the attached Specific Features of the Circulation, Including the Specific Features of State Registration, of Medical Devices in the Event of Their Shortage or the Risk of a Shortage Arising in Connection with the Introduction of Economic Restrictive Measures Against the Russian Federation.<\/p>\n

2. The Clause has ceased to have effect.
\n(as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240).<\/p>\n

3. This Resolution shall enter into force on the date of its official publication and shall remain in effect until January 1, 2028. (<\/p>\n

Chairman of the Government
\nof the Russian Federation<\/p>\n

M. MISHUSTIN<\/p>\n

APPROVED<\/p>\n

by Resolution of the Government
\nof the Russian Federation
\ndated April 1, 2022 No. 552<\/p>\n

 <\/p>\n

SPECIFIC FEATURES OF THE CIRCULATION, INCLUDING SPECIFIC FEATURES OF THE STATE REGISTRATION, OF MEDICAL DEVICES IN THE EVENT OF THEIR SHORTAGE OR THE RISK OF A SHORTAGE ARISING IN CONNECTION WITH THE INTRODUCTION OF ECONOMIC RESTRICTIVE MEASURES AGAINST THE RUSSIAN FEDERATION<\/strong>
\n(as amended by Resolutions of the Government of the Russian Federation dated September 19, 2022 No. 1643, December 29, 2022 No. 2525, December 21, 2024 No. 1851, and February 28, 2025 No. 240)<\/p>\n

I. General Provisions<\/strong><\/p>\n

1. This document, in connection with the introduction of economic restrictive measures against the Russian Federation, establishes specific features of the circulation of medical devices, including specific features of the state registration of medical devices and amendments to documents contained in the registration dossier for a domestically manufactured medical device (a medical device for which the registry entry in the State Register of Medical Devices and Organizations (Individual Entrepreneurs) Engaged in the Manufacture and Production of Medical Devices (hereinafter, respectively, the \u201cregistry entry\u201d and the \u201cState Register\u201d) confirming the fact of its state registration, or the application for its state registration, identifies as the manufacturer (producer) a legal entity or an individual registered as an individual entrepreneur that is a resident of the Russian Federation and also has its place of manufacture (production site) in the territory of the Russian Federation (hereinafter, a \u201cdomestically manufactured medical device\u201d).
\n(as amended by Resolutions of the Government of the Russian Federation dated September 19, 2022 No. 1643 and February 28, 2025 No. 240)
\n2. State registration of medical devices pursuant to this document shall be carried out by the Federal Service for Surveillance in Healthcare (hereinafter, the \u201cregistration authority\u201d).
\n3. The fact of state registration of a medical device pursuant to this document shall be confirmed by a registry entry in the State Register. (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nState registration pursuant to this document shall remain valid until January 1, 2028. (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\n4. The list of types of medical devices subject to circulation pursuant to this document (hereinafter, the \u201clist of medical devices\u201d) shall be approved by an Interagency Commission, consisting of representatives of the Ministry of Health of the Russian Federation, the Ministry of Industry and Trade of the Russian Federation, the Ministry of Finance of the Russian Federation, the Ministry of Economic Development of the Russian Federation, the Federal Antimonopoly Service, the Federal Customs Service, the Federal Tax Service, the registration authority, as well as representatives of other authorities and organizations, where necessary (hereinafter, the \u201cInteragency Commission\u201d).
\nThe regulations governing the Interagency Commission, including the procedure for organizing its work, the procedure for determining shortages of medical devices or the risk of such shortages arising, the criteria for inclusion of medical devices in and exclusion of medical devices from the list of medical devices, and the composition of the Interagency Commission shall be approved by the registration authority in coordination with the Ministry of Health of the Russian Federation, the Ministry of Industry and Trade of the Russian Federation, the Ministry of Finance of the Russian Federation, the Ministry of Economic Development of the Russian Federation, and the Federal Antimonopoly Service. (as amended by Resolution of the Government of the Russian Federation dated September 19, 2022 No. 1643)
\nThe list of medical devices shall include:
\nmedical devices in the event of an existing shortage or a risk of such shortage arising;
\nmedical devices in respect of which proposals for the supply of medical devices at a price below the average market price have been submitted to the Interagency Commission;
\nother medical devices determined by the Interagency Commission.
\nThe list of medical devices shall be published on the official website of the registration authority on the Internet within a period not exceeding 2 business days from the date on which the Interagency Commission approves the list or amendments thereto.
\n5. The following basic terms are used in this document:
\n\u201cApplicant\u201d means the manufacturer (producer) of a medical device, the authorized representative of the manufacturer (producer), or a person importing a medical device into the Russian Federation for the purpose of its state registration;
\n\u201cperson importing a medical device into the Russian Federation for the purpose of its state registration\u201d means a legal entity or an individual registered as an individual entrepreneur, being a resident of the Russian Federation, responsible for all matters relating to the circulation of the medical device being registered and carrying out the procurement, storage, division of products into quantities by batch that do not affect the characteristics of the products, or sale of such products without affecting their quality, efficacy, or safety;
\nThe fourth paragraph has ceased to have effect. (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nOther terms used in this document shall have the meanings established by the Rules for State Registration of Medical Devices, approved by Resolution of the Government of the Russian Federation dated November 30, 2024 No. 1684, \u201cOn Approval of the Rules for State Registration of Medical Devices\u201d (hereinafter, the \u201cRegistration Rules\u201d). (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\n6. State registration of medical devices with a low degree of potential risk of their use (except for medical devices supplied in sterile form) included in the list of medical devices shall, at the applicant’s discretion, be carried out either in accordance with Clauses 13\u201322 of this document or in accordance with Clauses 23\u201329 of this document.
\n7. The registration authority shall decide to cancel the state registration of a medical device registered pursuant to the provisions of this document in accordance with Section VIII of the Registration Rules, except for the cases provided for in subparagraphs \u201ce\u201d (where applicable) and \u201cf\u201d of Clause 137 of the Registration Rules, as well as where the registration authority identifies inaccurate information in the documents and materials relating to the medical device submitted to the Interagency Commission for the purpose of including the type of medical device in the list of medical devices, where such inaccurate information affected the outcome of the decision. (as amended by Resolutions of the Government of the Russian Federation dated September 19, 2022 No. 1643 and February 28, 2025 No. 240)
\nCancellation of the state registration of a foreign-manufactured medical device registered in accordance with the requirements of the legislation of the Russian Federation governing the state registration of medical devices shall not be carried out on the basis of an application submitted to the registration authority by the manufacturer (producer) of the medical device or the authorized representative of the manufacturer (producer) requesting cancellation of the state registration of the medical device. (as amended by Resolution of the Government of the Russian Federation dated September 19, 2022 No. 1643)
\n8. Federal state budgetary institutions under the authority of the registration authority (hereinafter, the \u201cexpert institution\u201d) shall, at the applicants’ request and on a fee-paying basis, provide consultations prior to commencement of the state registration procedure on matters relating to procedures associated with the state registration of medical devices, including preliminary analysis and assessment of the registration dossier.
\nThe consultation referred to in the first paragraph of this Clause shall not be mandatory for obtaining the state service for the state registration of medical devices.
\n9. In order to ensure the principles of independence and impartiality in conducting the assessment of the quality, efficacy, and safety of a medical device, as well as to eliminate the possibility of a conflict of interest, officials of expert institutions who provided the consultation referred to in Clause 8 of this document may not conduct the assessment of the quality, efficacy, and safety of the medical device in respect of which such consultation was provided.
\n10. During the circulation of medical devices, whether included in the list of medical devices or not included therein, restriction of the interchangeability of medical devices by means of special technical or software tools or by other means shall not be permitted.
\n11. A medical device whose manufacturer (producer) has established in the operational documentation a limited list of consumables may be used with a consumable manufactured (produced) by another manufacturer (producer) and registered as a medical device, provided that the manufacturer (producer) has confirmed during the state registration procedure that joint use with the relevant medical device is possible.
\nIn such case, the joint use of the medical device with the consumable shall take into account the specific requirements established in the manufacturer’s (producer’s) operational documentation for the consumable.
\n11(1). Maintenance of medical devices may be performed using components or accessories not specified in the manufacturer’s (producer’s) technical and\/or operational documentation, provided that the safety of their joint use has been confirmed by technical testing and, where applicable, toxicological studies conducted by the federal state budgetary institution \u201cAll-Russian Research and Testing Institute of Medical Engineering\u201d of the Federal Service for Surveillance in Healthcare (hereinafter, the \u201cinstitution\u201d), as well as by clinical trials conducted in accordance with the procedure established pursuant to Part 8 of Article 38 of the Federal Law \u201cOn the Fundamentals of Health Protection of Citizens in the Russian Federation.\u201d (as amended by Resolution of the Government of the Russian Federation dated December 29, 2022 No. 2525)
\nThe decision on whether the results of clinical trials must be submitted shall be made by the institution during the technical testing and, where applicable, toxicological studies. (as amended by Resolution of the Government of the Russian Federation dated December 29, 2022 No. 2525)
\nInformation on components or accessories of medical devices not specified in the manufacturer’s (producer’s) technical and\/or operational documentation shall be published on the official website of the institution on the Internet. (as amended by Resolution of the Government of the Russian Federation dated December 29, 2022 No. 2525)
\n11(2). The list of documents to be submitted to the institution and the requirements for their content, the form of the conclusion on the possibility (impossibility) of using components or accessories of a medical device not specified in the manufacturer’s (producer’s) technical and\/or operational documentation, as well as the list of information on components or accessories of a medical device not specified in the manufacturer’s (producer’s) technical and\/or operational documentation to be published on the official website of the institution on the Internet shall be approved by the registration authority. (as amended by Resolutions of the Government of the Russian Federation dated December 29, 2022 No. 2525 and February 28, 2025 No. 240)
\n11(3). Following the technical testing and, where applicable, toxicological studies, as well as the review of the documents submitted in accordance with the list and form specified in Clause 11(2) of this document and the results of clinical trials, the institution shall issue a conclusion on the possibility (impossibility) of using components or accessories of a medical device not specified in the manufacturer’s (producer’s) technical and\/or operational documentation. (as amended by Resolution of the Government of the Russian Federation dated December 29, 2022 No. 2525)
\n12. The state duty for actions performed by the registration authority in connection with the state registration of medical devices shall be paid in accordance with the legislation of the Russian Federation on taxes and duties.<\/p>\n

II. Specific Features of the State Registration of Medical Devices Included in the List of Medical Devices<\/strong><\/p>\n

13. For the state registration of a medical device, the applicant shall submit to the expert institution, using the federal state information system \u201cUnified Portal of State and Municipal Services (Functions)\u201d (hereinafter referred to as the \u201cUnified Portal\u201d), the following documents and information: (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nan application for state registration of the medical device, prepared in accordance with the requirements for the content of such application established by the Registration Rules. Where a medical device is imported into the Russian Federation for the purpose of its state registration, the application for state registration of the medical device shall contain the following information concerning the person importing the medical device into the Russian Federation: (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nfor a legal entity: its full and abbreviated name (if applicable), including transliteration, organizational and legal form, taxpayer identification number (for manufacturers that are residents of the Russian Federation), registered address, telephone number and e-mail address; (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nfor an individual entrepreneur: surname, first name and patronymic (if applicable), details of the identity document, taxpayer identification number (for manufacturers that are residents of the Russian Federation), residential address, telephone number and e-mail address; (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\na copy (copies) of the document(s) confirming the authority of the authorized representative of the manufacturer to represent the interests of the manufacturer, assume responsibility for the circulation of the medical device in the territory of the Russian Federation, including matters relating to conformity assessment procedures and state registration, as well as to certify the manufacturer’s documents, provided that such authority took effect before the relevant documents specified in this paragraph were executed (if applicable); (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\na copy (copies) of the document(s) confirming the authority of the person importing the medical device into the Russian Federation for the purpose of its state registration to certify the manufacturer’s documents, provided that such authority took effect before the relevant documents specified in this paragraph were executed (if applicable); (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\ndocuments confirming that the medical device is lawfully owned by the person importing the medical device into the Russian Federation for the purpose of its state registration (if applicable);
\nthe manufacturer’s technical documentation for the medical device, complying with the requirements approved by the Ministry of Health of the Russian Federation;
\nthe manufacturer’s operating documentation for the medical device, complying with the requirements approved by the Ministry of Health of the Russian Federation;
\nphotographic images of the general appearance of the medical device together with the accessories necessary for its intended use (measuring at least 18 \u00d7 24 cm);
\nphotographic images of the electronic storage medium and software interface (if applicable) (measuring at least 18 \u00d7 24 cm) – for software that is a medical device, including software using artificial intelligence technologies;
\ndocuments confirming the results of technical testing of the medical device (hereinafter, \u201ctechnical testing\u201d), 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, where such interaction\/contact is necessary for their function (hereinafter, \u201ctoxicological studies\u201d), and clinical trials of the medical device (hereinafter, \u201cclinical trials\u201d) conducted in accordance with the standard testing program applicable to the relevant type of medical device, developed by the expert institution (hereinafter, the \u201cstandard program\u201d) and published on the official website of the expert institution, where applicable; or documents confirming conformity assessment of the medical device in the form of technical testing, toxicological studies and clinical trials for the purposes of state registration of medical devices, in accordance with the procedure established by the Ministry of Health of the Russian Federation. (as amended by Resolution of the Government of the Russian Federation dated September 19, 2022 No. 1643)
\nTechnical testing and toxicological studies under the standard program shall be conducted by a testing laboratory (center) accredited within the national accreditation system and authorized to conduct technical testing and\/or toxicological studies, within the scope of its accreditation. Clinical trials under the standard program shall be conducted by a medical organization meeting the requirements established by the Registration Rules and conducting clinical trials. (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nFor medical devices manufactured in the Russian Federation (except implantable medical devices and medical devices supplied in sterile form), at the applicant’s option, the state registration application may be accompanied by documents from the manufacturer and\/or organizations conducting technical testing and toxicological studies (the results of the relevant tests), enabling assessment of the methods (methodologies) used and the list of testing equipment employed.
\nFor medical devices manufactured outside the Russian Federation (except software that is a medical device, including software using artificial intelligence technologies, and in vitro diagnostic medical devices), at the applicant’s option, copies of documents confirming registration of the medical device in the country of manufacture in accordance with the applicable procedure may be submitted, together with documents confirming the clinical efficacy and safety of the medical device being registered. In such case, the results of clinical trials of the medical device conducted in the Russian Federation in accordance with the procedure established by an order of the Ministry of Health of the Russian Federation need not be submitted;
\ndocuments confirming the results of testing the medical device for the purpose of type approval of measuring instruments, where the medical device qualifies as a measuring instrument within the scope of state regulation of measurement uniformity, the list of such medical devices being approved by the Ministry of Health of the Russian Federation (hereinafter, \u201ctesting of the medical device for type approval of measuring instruments\u201d); (as amended by Resolution of the Government of the Russian Federation dated September 19, 2022 No. 1643)
\ninformation concerning notifications of the import of medical devices for the purpose of their state registration submitted to the registration authority (if applicable); (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nocuments confirming the possibility of manufacturing at the address(es) specified in the application for state registration of the medical device (manufacturing site(s)), including documents confirming the availability of manufacturing conditions and\/or copies of certificates of conformity of the quality management system with the requirements of GOST ISO 13485 \u201cMedical Devices \u2014 Quality Management Systems \u2014 Requirements for Regulatory Purposes\u201d or the corresponding international ISO 13485 standard (where available);
\nother documents characterizing the quality, efficacy and safety of the medical device (where available);
\nParagraph eighteen \u2014 repealed. (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nWhere the documents specified above are prepared in a foreign language, they shall be submitted together with a duly certified translation into Russian.
\nThe manufacturer’s documents specified in this paragraph, except for the documents referred to in the fifth and sixth paragraphs of this clause, shall be certified by the manufacturer or its authorized representative (or by the person importing the medical device into the Russian Federation for the purpose of its state registration), provided that a document or documents confirming the authority of the authorized representative (or such importer) to certify these documents, and which took effect before the relevant documents specified in this paragraph were executed, are submitted to the expert institution. (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nWhen submitting an application for state registration of a medical device under this clause, the authority of the applicant’s representative to submit the relevant application shall be confirmed through the authority platform of the Unified Portal. (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nThe documents specified in this clause must be submitted 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 verification key certificate of which was created and is used in the infrastructure that ensures the information and technological interaction of information systems used to provide state and municipal services in electronic form, in accordance with the procedure established by the Government of the Russian Federation (hereinafter referred to as an enhanced unqualified electronic signature) of the applicant. (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nPaper documents contained in the registration dossier, electronic images of which are submitted by the applicant, shall be duly certified. (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nThe documents specified in this clause must be prepared in a multi\u2011color format with a resolution of at least 300 dots per inch in PDF format, with a text layer that allows for selecting and copying blocks, as well as searching. (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nThe size of any individual registration dossier file shall not exceed 100 MB. (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nEach document contained in the registration dossier must indicate its date of issuance. (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nWithin 15 working days from the date of receipt of the documents specified in paragraph 13 of this document, the expert institution shall assess their completeness, as well as the reliability of the information contained therein, the sufficiency and completeness, including the sufficiency of the volume of technical tests, toxicological studies, clinical trials, and tests of the medical device for the purpose of type approval of measuring instruments, draw up an opinion on the possibility (impossibility) of state registration of the medical device in the form established by the Ministry of Health of the Russian Federation for the purposes of quality, efficacy and safety examination of the medical device, and send it to the registering authority. (as amended by Resolution of the Government of the Russian Federation dated September 19, 2022 No. 1643)
\nTo the opinion of the expert institution specified in the first paragraph of this paragraph, the documents submitted by the applicant in accordance with paragraph 13 of this document (in electronic form by posting in the automated information system of the registering authority) and paragraph 15 of this document shall be attached. (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\n15. If the expert institution identifies incompleteness, and\/or unreliability, and\/or insufficiency, and\/or incompleteness of documents and\/or information specified in paragraph 13 of this document, the expert institution shall, within 5 working days from the date of their receipt, send a request to the applicant via the subsystem of the unified personal cabinet on the unified portal (hereinafter referred to as the applicant’s unified personal cabinet) for the submission of the necessary documents and\/or information specified in paragraph 13 of this document, indicating the nature of the remarks and the way to eliminate them. (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nThe applicant is obliged to submit a response to the request of the expert institution within a period not exceeding 30 working days from the date of the request. The expert institution shall prepare an opinion within 5 working days from the date of receipt of the applicant’s response to the request.
\nIf the applicant does not submit a response within 30 working days, the expert institution shall prepare an opinion based on the documents available at its disposal.
\nThe time from the date of the expert institution’s request until the date of receipt of the response to the request or notification of non-submission of the response to the request by the expert institution shall not be counted when calculating the term for conducting the quality, efficacy and safety examination of the medical device. (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\n16. An opinion on the impossibility of state registration of a medical device shall be drawn up by the expert institution if there are the following grounds (one or more):
\na) there is no evidence that the medical device complies with the requirements of the manufacturer’s documentation;
\nb) there is no evidence of the quality, and\/or efficacy, and\/or safety of the medical device;
\nc) the risk of harm to the health of citizens and medical workers due to the use of the medical device exceeds the effectiveness of its use;
\nd) the medical device is not included in the list of medical devices;
\ne) the documents specified in paragraph 13 of this document have not been submitted in full, including within the framework of paragraph 15 of this document, and\/or unreliable information has been identified in them.
\n17. Within 7 working days from the date of receipt of the opinion specified in paragraph 14 of this document, the registering authority shall:
\na) make a decision on state registration of the medical device or on refusal of state registration of the medical device, which is formalized by an order of the registering authority, and notify the applicant of the decision made by posting the corresponding notification in the form of an electronic document signed by a strengthened qualified electronic signature of an authorized official in the unified personal cabinet of the applicant and the applicant’s personal cabinet in the automated information system of the registering authority (hereinafter referred to as the applicant’s electronic cabinet); (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nb) make a registry entry in the state register. (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\n18. In relation to medical devices specified in the list of medical devices, it is allowed to make changes to the documents contained in the registration dossier for a medical device on the grounds provided by the Registration Rules and not requiring an examination of the quality, efficacy and safety of the medical device, as well as in the case of a change in the information about the person carrying out the import of the medical device to the Russian Federation for the purpose of its state registration.
\nMaking changes to the documents contained in the registration dossier for a medical device registered in accordance with this document that require an examination of the quality, efficacy and safety of the medical device shall be carried out in the manner prescribed by the Registration Rules, within a period not exceeding 25 working days from the date of receipt of the application for making changes and the set of documents provided for by the Rules.
\n19. To make changes to the documents contained in the registration dossier specified in paragraph 18 of this document, the applicant shall submit to the registering authority using the unified portal the following documents:
\nan application for making changes to the documents contained in the registration dossier (hereinafter referred to as the application for making changes), drawn up in accordance with the requirements for the content of the application for making changes established by the Registration Rules. In the case of import of a medical device to the Russian Federation for the purpose of making changes to the documents contained in the registration dossier, the application for making changes shall contain the following information about the person carrying out the import of the medical device to the Russian Federation: (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nin relation to a legal entity \u2014 the full and abbreviated (if applicable) name (with transliteration), organizational and legal form, tax identification number (for manufacturers who are residents of the Russian Federation), place of location, as well as phone number and email address; (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nin relation to an individual registered as an individual entrepreneur \u2014 surname, first name and patronymic (if applicable), identity document details, tax identification number (for manufacturers who are residents of the Russian Federation), place of residence, as well as phone number and email address; (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\na copy (copies) of the document (documents) confirming (confirming) the powers of the authorized representative of the manufacturer (maker) to represent the interests of the manufacturer (maker), bear responsibility in part of the circulation of the medical device in the Russian Federation, including in part of compliance assessment and state registration procedures, as well as to certify the documents of the manufacturer (maker) and entered into force before the execution of the relevant documents specified in this paragraph (if applicable); (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\na copy (copies) of the document (documents) confirming (confirming) the powers of the person carrying out the import of the medical device to the Russian Federation for the purpose of its state registration to certify the documents of the manufacturer (maker) and entered into force before the execution of the relevant documents specified in this paragraph (if applicable); (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\ndocuments confirming that the medical device belongs to the person carrying out the import of the medical device to the Russian Federation on legal grounds;
\ndocuments confirming the possibility of carrying out production at the address (addresses) specified in the application for making changes (production site (production sites) (documents confirming the presence of production conditions, and\/or copies of certificates of compliance of the quality management system with the requirements of the GOST ISO 13485 “Medical devices. Quality management systems. Requirements for regulatory purposes” or the corresponding international ISO 13485 standard) (if applicable);
\nDocuments and information on the relevant changes, including documents confirming the changes and indicating that the introduction of these changes does not entail any alteration of the properties and characteristics of the medical device affecting its safety, quality and efficacy, or improves its properties and characteristics, provided that the functional purpose and\/or operating principle of the medical device remain unchanged;
\nParagraphs eight to ten \u2014 have become invalid (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nIf the said documents are drawn up in a foreign language, they shall be submitted together with a translation into Russian certified in accordance with the established procedure.
\nParagraph twelve \u2014 has become invalid (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nWhen submitting an application for making changes in accordance with this paragraph, the authority of the applicant\u2019s representative to file the relevant application shall be confirmed using the functionality of the authority platform of the unified system (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nThe documents specified in this paragraph shall be submitted 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 (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nPaper documents contained in the registration dossier, electronic images of which are submitted by the applicant, must be certified in accordance with the established procedure (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nThe documents specified in this paragraph must be prepared in color format with a resolution of not less than 300 dots per inch, in PDF format with a text layer enabling selection and copying of blocks, as well as text search (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nThe size of any file in the registration dossier must not exceed 100 MB (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nEach document contained in the registration dossier must necessarily indicate the date of its issuance (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\n20. Within 15 working days from the date of receipt of the application for making changes and the documents provided for in paragraph 19 of this document, the registering authority shall verify the completeness and reliability of the information contained therein and shall:
\na) adopt a decision on making changes to the documents contained in the registration dossier, which shall be formalized by an order of the registering authority, enter the relevant information into the state register, or adopt a decision to discontinue further consideration of the application for making changes and the documents provided for in paragraph 19 of this document (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240);
\nb) notify the applicant in writing of the decision taken (by sending a notification in the form of an electronic document signed with an enhanced qualified electronic signature of an authorized official, by posting it in the applicant\u2019s unified personal cabinet and the applicant\u2019s electronic cabinet) (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\n21. The registering authority shall compile the registration dossier for a medical device from the following documents:
\na) the application for state registration and the documents attached thereto, as well as the application for making changes and the documents attached to the application for making changes;
\nb) the opinion on the possibility (impossibility) of state registration of the medical device;
\nc) the decision on state registration of the medical device, formalized by an order of the registering authority;
\nd) copies of notifications issued by the registering authority (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240);
\ne) the subparagraph has become invalid (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\n22. During the period of validity of the state registration of a medical device carried out in accordance with paragraphs 13\u201321 of this document, the manufacturer (producer) or the authorized representative of the manufacturer (producer) shall have the right to submit to the registering authority an application for state registration, drawn up in accordance with the requirements for the content of such an application established by the Registration Rules, and the documents provided for by the Registration Rules, in order to undergo the state registration procedure for the medical device in accordance with Section III or Section IV of the Registration Rules. Information on notifications of import of the medical device for the purpose of its state registration submitted to the registering authority shall not be indicated in the application for state registration of such a medical device (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nFor the purposes of state registration of such medical devices, the examination of the application for state registration of the medical device and the documents provided for by the Registration Rules shall be carried out simultaneously with the examination of the completeness and results of the technical tests, toxicological studies, clinical trials conducted, as well as tests for the purpose of type approval of measuring instruments (as amended by Resolution of the Government of the Russian Federation dated September 19, 2022 No. 1643)<\/p>\n

III. Features of the state registration of medical devices with a low degree of potential risk of their use (excluding medical devices manufactured in a sterile form) included in the list of medical devices<\/strong><\/p>\n

23. For the state registration of a medical device with a low degree of potential risk of its use (excluding medical devices manufactured in a sterile form) included in the list of medical devices, the applicant shall submit to the registering authority using the applicant\u2019s unified personal account the following documents and information: (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nan application for state registration of the medical device in accordance with the requirements for the content of such an application established by the Registration Rules (excluding the information provided for in subparagraphs \u201cm\u201d\u2013\u201cr\u201d and \u201cx\u201d of paragraph 64 of the Registration Rules). If the medical device is imported into the Russian Federation for the purpose of state registration, the application for state registration of the medical device must contain the following information about the person importing the medical device into the Russian Federation: (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nfor a legal entity \u2014 full and abbreviated (if applicable) names (with transliteration), legal form, taxpayer identification number (for manufacturers who are residents of the Russian Federation), address of the location, as well as phone number and email address; (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nfor an individual registered as an individual entrepreneur \u2014 surname, name and patronymic (if applicable), details of the identity document, taxpayer identification number (for manufacturers who are residents of the Russian Federation), residential address, as well as phone number and email address. (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\na copy (copies) of the document(s) confirming the authority of the manufacturer\u2019s (producer\u2019s) authorized representative to represent the interests of the manufacturer (producer), bear responsibility regarding the circulation of the medical device in the territory of the Russian Federation, including with respect to conformity assessment procedures and state registration, as well as to certify the manufacturer\u2019s (producer\u2019s) documents, which entered into force prior to the execution of the relevant documents provided for in this paragraph (if applicable); (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\na copy (copies) of the document(s) confirming the authority of the person importing the medical device into the Russian Federation for the purpose of its state registration to certify the manufacturer\u2019s (producer\u2019s) documents, which entered into force prior to the execution of the relevant documents provided for in this paragraph (if applicable); (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\na copy of the contract concluded with the institution for conducting technical tests, toxicological studies, tests for the purpose of type approval of measuring instruments (if applicable); (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\ndocuments confirming that the medical device belongs to the person importing the medical device into the Russian Federation for the purpose of its state registration on lawful grounds;
\ntechnical documentation of the manufacturer (producer) for the medical device, compliant with the requirements approved by the Ministry of Health of the Russian Federation;
\noperational documentation of the manufacturer (producer) for the medical device, compliant with the requirements approved by the Ministry of Health of the Russian Federation;
\nphotographic images of the general view of the medical device together with the accessories necessary for the intended use of the medical device (size not less than 18 by 24 centimeters);
\nphotographic images of the electronic medium and the software interface (if applicable) (size not less than 18 by 24 centimeters) \u2014 for software that is a medical device;
\nParagraph 10 \u2014 repealed. (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nIf the said documents are drawn up in a foreign language, they shall be submitted with a translation into Russian certified in the established manner.
\nParagraph 12 \u2014 repealed. (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nWhen submitting an application for state registration of a medical device in accordance with this paragraph, the authority of the applicant\u2019s representative to submit the relevant application shall be confirmed using the authority platform functionality of the unified portal. (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nThe documents specified in this paragraph shall be submitted 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. (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nPaper documents contained in the registration dossier, electronic images of which are submitted by the applicant, must be certified in the established manner. (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nThe documents specified in this paragraph must be in full color with a resolution of not less than 300 dpi in PDF format with a text layer enabling selection and copying of blocks, as well as search functionality. (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nThe size of any file in the registration dossier must not exceed 100 MB. (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nEach document contained in the registration dossier must necessarily indicate the date of its issuance. (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\n23(1). The state registration of a medical device with a low degree of potential risk of its use (excluding medical devices manufactured in a sterile form) included in the list of medical devices shall be carried out once for one name of the medical device of one manufacturer (producer). (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\n24. Within a period not exceeding 5 working days from the date of receipt of the application and the documents provided for in paragraph 23 of this document, the registering authority shall make a decision on the state registration of the medical device, formalized by an order of the registering authority, enter a registry entry in the state register, and notify the applicant of the decision taken (by sending a notification in the form of an electronic document signed with an enhanced qualified electronic signature of an authorized official by posting it in the applicant\u2019s unified personal account and the applicant\u2019s electronic account). (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nIf the documents specified in paragraph 23 of this document and\/or the information contained in these documents are not submitted in full and\/or are insufficient and\/or incomplete and\/or unreliable, these documents shall not be accepted by the registering authority, of which the registering authority shall notify the applicant (by sending a notification in the form of an electronic document signed with an enhanced qualified electronic signature of an authorized official by posting it in the applicant\u2019s unified personal account and the applicant\u2019s electronic account). (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nThe applicant bears responsibility for the reliability of the information submitted in the registration dossier. (as amended by Resolution of the Government of the Russian Federation dated September 19, 2022 No. 1643)
\n25. Within a period not exceeding 5 working days from the date the registering authority enters in the state register a registry entry confirming the fact of state registration of a medical device with a low degree of potential risk of its use (excluding medical devices manufactured in a sterile form) in accordance with paragraph 24 of this document, the applicant must, in accordance with the concluded contract, submit to the institution a sample (samples) of the medical device for conducting technical tests, toxicological studies, tests for the purpose of type approval of measuring instruments, and also pay for the institution\u2019s services. (as amended by Resolutions of the Government of the Russian Federation dated September 19, 2022 No. 1643, December 29, 2022 No. 2525, and February 28, 2025 No. 240)
\n26. Within a period not exceeding 50 working days from the date of receipt of the sample (samples) of the medical device with a low degree of potential risk of its use (excluding medical devices manufactured in a sterile form), the institution shall conduct the tests and studies specified in paragraph 25 of this document in accordance with the standard program depending on the type of medical device, developed by the expert institution and published on the official website of the expert institution on the Internet (if applicable), and shall: (as amended by Resolution of the Government of the Russian Federation dated September 19, 2022 No. 1643)
\n\u0430) prepare and issue to the applicant documents confirming the results of the tests and studies specified in paragraph 25 of this document; (as amended by Resolution of the Government of the Russian Federation dated September 19, 2022 No. 1643)
\n\u0431) send to the registering authority documents confirming the results of the tests and studies specified in paragraph 25 of this document, and a cover letter indicating information on the establishment (or non\u2011establishment) of facts and circumstances creating a threat to the life and health of citizens and medical workers during the use and operation of the medical device. (as amended by Resolution of the Government of the Russian Federation dated September 19, 2022 No. 1643)
\n27. Within a period not exceeding 150 working days from the date of state registration of a medical device with a low degree of potential risk of its use (excluding medical devices manufactured in a sterile form) included in the list of medical devices, the manufacturer (producer) or the authorized representative of the manufacturer (producer) must submit to the registering authority an application for state registration and a set of documents (excluding the documents specified in paragraph 23 of this document and documents confirming the results of the tests and studies specified in paragraph 26 of this document, if no changes have been made to them and\/or additional tests and\/or studies have not been conducted) provided for in Section III or Section IV of the Registration Rules, to undergo the state registration procedure for the medical device and for the registering authority to enter in the state register a registry entry confirming the fact of state registration of the medical device in accordance with the Registration Rules. Information on notifications of import of the medical device for the purpose of its state registration submitted to the registering authority shall not be indicated in the application for state registration of such a medical device. (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nFor the purpose of state registration of the medical devices specified in the first paragraph of this item, the examination of the application for state registration of the medical device and the documents provided for in the Registration Rules shall be carried out simultaneously with the examination of the completeness and results of the conducted technical tests, toxicological studies, clinical trials, as well as tests for the purpose of type approval of measuring instruments. (as amended by Resolution of the Government of the Russian Federation dated September 19, 2022 No. 1643)
\nParagraph 3 \u2014 repealed. (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\n28. Amendments to the documents contained in the registration dossier of a medical device with a low degree of potential risk of its use (excluding medical devices manufactured in a sterile form) included in the list of medical devices shall be made after the decision on state registration of the medical device has been adopted in accordance with the Registration Rules.
\n29. The grounds for the registering authority to make a decision to cancel the state registration of a medical device with a low degree of potential risk of its use (excluding medical devices manufactured in a sterile form) included in the list of medical devices are the grounds specified in the first paragraph of paragraph 7 of this document, as well as: (as amended by Resolution of the Government of the Russian Federation dated September 19, 2022 No. 1643)
\n\u0430) an opinion of the expert institution based on the results of the examination of the quality, efficacy and safety of the medical device indicating that the quality and\/or efficacy and\/or safety of the medical device are not confirmed by the data obtained, and\/or that the risk of harm to the health of citizens and medical workers due to the use of the medical device exceeds the efficacy of its use, and\/or that the medical device does not comply with the requirements of regulatory documentation, technical and\/or operational documentation of the manufacturer (producer);
\nb) identification by the registering authority based on the results of state control over the circulation of medical devices of a discrepancy between the data on the efficacy and safety of the medical device and the data on the medical device contained in the documents and information submitted by the applicant in accordance with paragraph 23 of this document;
\nc) failure by the manufacturer (producer) of the medical device or the authorized representative of the manufacturer (producer) of the medical device to submit to the registering authority within a period not exceeding 150 working days from the date of state registration of the medical device with a low degree of potential risk of its use (excluding medical devices manufactured in a sterile form) included in the list of medical devices an application for state registration and a set of documents provided for by the Registration Rules for undergoing the state registration procedure for the medical device in accordance with the Registration Rules;
\nreceipt from the institution of information on the identification of facts and circumstances creating a threat to the life and health of citizens and medical workers during the use and operation of the medical device based on the results of the tests conducted in accordance with paragraph 26 of this document;
\ne) failure to comply with the requirements provided for in paragraph 25 of this document; (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nf) adoption by the registering authority of a decision to discontinue further consideration of the application for state registration of the medical device and the submitted documents in accordance with the Registration Rules; (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\ng) identification by the registering authority of unreliable information in the documents submitted by the applicant in accordance with paragraph 23 of this document within a period not exceeding 60 working days from the date of their submission to the registering authority. (as amended by Resolution of the Government of the Russian Federation dated September 19, 2022 No. 1643)<\/p>\n

IV. Specific features of amending documents contained in the registration dossier for a domestically produced medical device<\/strong><\/p>\n

30. The following changes to the documents contained in the registration dossier for a domestically produced medical device (whether included in or not included in the list of medical devices registered in accordance with the requirements of the legislation of the Russian Federation in the field of state registration of medical devices, requiring an assessment of the quality, efficacy, and safety of the medical device) entail the need to conduct an expert assessment of the quality, efficacy, and safety of the medical device (as amended by Resolution of the Government of the Russian Federation dated September 19, 2022 No. 1643)
\nchanges in information about purchased items, raw materials, materials, and components; (as amended by Resolution of the Government of the Russian Federation dated September 19, 2022 No. 1643);
\nchanges in information about constituent parts, spare parts, and accessories. (as amended by Resolution of the Government of the Russian Federation dated September 19, 2022 No. 1643)
\nThe validity period of the state registration shall not be altered upon making the changes stipulated by this paragraph (as amended by Resolutions of the Government of the Russian Federation dated September 19, 2022 No. 1643 and February 28, 2025 No. 240)
\n31. To amend the documents contained in the registration dossier on the grounds specified in paragraph 30 of this document, the applicant shall, not later than 30 working days after the relevant data have changed, submit to the registering authority using the applicant\u2019s unified personal account the following documents (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nan application for amending the documents, drawn up in accordance with the requirements for the content of such an application established by the Registration Rules;
\na copy (copies) of the document (documents) confirming (confirming) the powers of the authorized representative of the manufacturer (maker) to represent the interests of the manufacturer (maker), bear responsibility regarding the circulation of the medical device in the Russian Federation, including in relation to procedures for assessing conformity and state registration, as well as to certify the documents of the manufacturer (maker) and which entered into force before the execution of the relevant documents (if applicable); (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\ndocuments and information regarding the relevant changes, including documents confirming the changes and demonstrating that the introduction of these changes does not entail a change in the properties and characteristics of the medical device affecting its safety, quality, and efficacy, or improves its properties and characteristics while maintaining the functional purpose and\/or principle of operation of the medical device;
\nParagraph five. – Invalid. (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\ndocuments of the manufacturer and\/or organizations conducting technical tests, toxicological studies, clinical tests (results of the relevant tests), confirming that the proposed changes do not entail a change in the properties and characteristics affecting the quality, efficacy, and safety of the medical device, or improve such properties and characteristics while maintaining the functional purpose and\/or principle of operation of the medical device, as well as allowing an assessment of the methods (methodologies) used and the list of test equipment employed;
\nParagraph seven. – Invalid. (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nIf the specified documents are drawn up in a foreign language, they shall be submitted with a translation into Russian certified in the established procedure.
\nWhen submitting an application for amending in accordance with this paragraph, the powers of the applicant\u2019s representative to submit such an application shall be confirmed using the functionality of the unified portal\u2019s authority platform (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240).
\nThe documents specified in this paragraph shall be submitted in the form of electronic documents or electronic images of documents signed by the applicant with an enhanced qualified electronic signature or an enhanced unqualified electronic signature (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240).
\nDocuments on paper contained in the registration dossier, electronic images of which are submitted by the applicant, shall be certified in the established procedure (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240).
\nThe documents specified in this paragraph shall be prepared in a multi-color format with a resolution of at least 300 dots per inch in PDF format with a text layer that allows blocks to be selected and copied, and for search to be performed (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240).
\nThe size of any of the registration dossier files shall not exceed 100 MB (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240).
\nA date of issuance shall be indicated in each document contained in the registration dossier (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240).
\n32. The expert assessment of the quality, efficacy, and safety of the medical device on the grounds specified in paragraph 30 of this document shall be conducted within a period not exceeding 5 working days from the day the expert institution receives from the registering authority the relevant assignment and the documents provided for in paragraph 31 of this document.
\nIf the expert institution identifies incompleteness, and\/or unreliability, and\/or insufficiency, and\/or incompleteness of the documents provided for in paragraph 31 of this document and\/or the information contained in these documents, the expert institution shall send a request to the registering authority that issued the assignment for the expert assessment to submit the necessary documents and\/or information. The request of the expert institution shall contain an exhaustive list of documents and\/or information required for the expert assessment (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nThe registering authority shall, within 2 working days from the date of receipt of the request from the expert institution, send a request to the applicant to submit the necessary documents and\/or information, indicating the nature of the remarks and the way to eliminate them. The request of the registering authority shall be sent once and shall be transmitted to the applicant in the form of an electronic document signed with an enhanced qualified electronic signature of the authorized official, either by sending it to the applicant\u2019s email address specified in the application for amendment or by placing it in the applicant\u2019s unified personal account and electronic cabinet (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nThe applicant shall be obliged to submit a response to the request of the registering authority via the unified personal account of the applicant within a period not exceeding 30 working days from the date of sending such a request (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240).
\nWithin 2 working days from the date of receipt of the applicant\u2019s response to the request of the registering authority, the registering authority shall send the response to the expert institution (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240).
\nIf the applicant fails to submit a response to the request of the registering authority after the expiration of 30 working days, the registering authority shall, within 2 working days, send to the expert institution a notification of the applicant\u2019s failure to submit a response to prepare an expert conclusion on the possibility (impossibility) of amending the documents contained in the registration dossier for the medical device based on the documents available to the expert institution (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240).
\nThe time period from the date of sending the request by the registering authority to the date of receipt of the applicant\u2019s response to the request or to the date of sending by the registering authority a notification of the applicant\u2019s failure to submit a response shall not be counted when calculating the term for conducting the expert assessment of the quality, efficacy, and safety of the medical device (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\nIf the registering authority identifies incompleteness, and\/or unreliability, and\/or insufficiency, and\/or incompleteness of the documents submitted by the applicant in response to the request of the registering authority and\/or the information contained in these documents, the registering authority shall, within 2 working days, send (in the form of an electronic document signed with an enhanced qualified electronic signature of the authorized official, by placing it in the applicant\u2019s unified personal account and electronic cabinet) a notification of the possibility for the applicant to submit revised documents and\/or information within the remaining period of 30 working days from the date of sending the request. If the applicant does not submit the requested documents and\/or information within the specified period, the expert assessment of the quality, efficacy, and safety of the medical device shall continue based on the documents and information available to the expert institution (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)
\n33. The registering authority shall, within 7 working days from the date of receipt of: a) the expert conclusion of the expert:
\na) Upon receipt of the expert institution\u2019s conclusion confirming the possibility of amending the documents contained in the registration dossier for the medical device, the registering authority shall make a decision to amend the documents contained in the registration dossier. This decision shall be formalized by an order of the registering authority; a registry entry shall be made in the state register; and the applicant shall be notified of the decision taken. The notification shall be sent in the form of an electronic document signed with an enhanced qualified electronic signature of an authorized official by posting it in the applicant\u2019s unified personal account and electronic cabinet (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240).
\nb) Upon receipt of the expert institution\u2019s conclusion indicating the impossibility of amending the documents contained in the registration dossier for the medical device, the registering authority shall make a decision to refuse to amend the documents contained in the registration dossier. This decision shall be formalized by an order of the registering authority, and a reasoned refusal shall be sent to 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\u2019s unified personal account and electronic cabinet (as amended by Resolution of the Government of the Russian Federation dated February 28, 2025 No. 240)<\/p>\n","protected":false},"excerpt":{"rendered":"

GOVERNMENT OF THE RUSSIAN FEDERATION RESOLUTION dated April 1, 2022 No. 552   ON APPROVAL OF THE SPECIFIC FEATURES OF THE CIRCULATION, INCLUDING THE SPECIFIC FEATURES OF STATE REGISTRATION, OF MEDICAL DEVICES IN THE EVENT OF THEIR SHORTAGE OR THE RISK OF A SHORTAGE ARISING IN CONNECTION WITH THE INTRODUCTION OF ECONOMIC RESTRICTIVE MEASURES AGAINST […]<\/p>\n","protected":false},"featured_media":2339,"template":"","categories":[25],"class_list":["post-2393","resources","type-resources","status-publish","has-post-thumbnail","hentry","category-regulatory-framework-en"],"_links":{"self":[{"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/resources\/2393","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/resources"}],"about":[{"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/types\/resources"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/media\/2339"}],"wp:attachment":[{"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/media?parent=2393"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/grandlocus.com\/en\/wp-json\/wp\/v2\/categories?post=2393"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}