Order No. 541n dated 26 May, 2026 by the Ministry of Health of the Russian Federation

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION
ORDER No. 541n dated May 26, 2026

ON APPROVAL OF THE PROCEDURE FOR REPORTING ALL CASES OF IDENTIFICATION OF ADVERSE EVENTS AT ALL STAGES OF THE CIRCULATION OF THE RELEVANT MEDICAL DEVICE IN THE TERRITORY OF THE RUSSIAN FEDERATION AND IN THE TERRITORIES OF OTHER STATES

Pursuant to paragraph 15 of Part 1 of Article 14 and Part 3 of Article 96 of Federal Law No. 323-FZ dated November 21, 2011, “On the Fundamentals of Health Protection of Citizens in the Russian Federation,” and subparagraph 5.2.192 of the Regulation on the Ministry of Health of the Russian Federation, approved by Resolution of the Government of the Russian Federation No. 608 dated June 19, 2012, I hereby order:
1. To approve the attached Procedure for Reporting All Cases of Identification of Adverse Events at All Stages of the Circulation of the Relevant Medical Device in the Territory of the Russian Federation and in the Territories of Other States.
2. To declare invalid Order No. 1113n of the Ministry of Health of the Russian Federation dated October 19, 2020, “On Approval of the Procedure for Reporting by Medical Device Circulation Entities of All Cases of Identification of Adverse Effects Not Specified in the Instructions for Use or Operating Manual of a Medical Device, Adverse Reactions to Its Use, Specific Features of Interaction Between Medical Devices, and Facts and Circumstances Posing a Threat to the Life and Health of Citizens and Healthcare Professionals During the Use and Operation of Medical Devices” (registered by the Ministry of Justice of the Russian Federation on December 7, 2020, Registration No. 61286).
3. This Order shall enter into force on September 1, 2026 and shall remain in effect until September 1, 2032.

Minister
M. A. MURASHKO

APPROVED
by Order No. 541n of the Ministry of Health of the Russian Federation
dated May 26, 2026

PROCEDURE FOR REPORTING ALL CASES OF IDENTIFICATION OF ADVERSE EVENTS AT ALL STAGES OF THE CIRCULATION OF THE RELEVANT MEDICAL DEVICE IN THE TERRITORY OF THE RUSSIAN FEDERATION AND IN THE TERRITORIES OF OTHER STATES

1. Entities engaged in the circulation of medical devices and carrying out activities specified in Part 3 of Article 38 of Federal Law No. 323-FZ dated November 21, 2011, “On the Fundamentals of Health Protection of Citizens in the Russian Federation” (hereinafter, “Federal Law No. 323-FZ”) <1>, including individuals using medical devices, except for entities engaged in the circulation of medical devices operating within the territory of the International Medical Cluster or within the territories of innovative scientific and technological centers (hereinafter, “medical device circulation entities”), shall, within twenty business days from the date on which an adverse event is identified <2>, submit to the Federal Service for Surveillance in Healthcare (Roszdravnadzor), through the automated information system of Roszdravnadzor, a report of the adverse event containing the information specified in Annex No. 1 to this Procedure.
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<1> Part 3 of Article 96 of Federal Law No. 323-FZ.

<2> Paragraph 15 of Part 1 of Article 14 of Federal Law No. 323-FZ.

2. The information specified in the adverse event report shall be supported by the relevant documents, copies of which shall be attached to the adverse event report, where available.
3. The adverse event report shall be registered in the “Medical Device Adverse Events” section of the automated information system of Roszdravnadzor on the day of its receipt.
4. If a medical device circulation entity that has submitted an adverse event report subsequently becomes aware of additional information concerning the adverse event, such information shall be submitted to Roszdravnadzor by filing a subsequent adverse event report.
5. With respect to Class 3 medical devices in terms of potential risk of use, as well as Class 2b medical devices in terms of potential risk of use that are implanted in the human body, for the purpose of confirming safety and clinical effectiveness during use, the manufacturer of the medical device or the manufacturer’s authorized representative shall conduct clinical monitoring of the medical device (hereinafter, “clinical monitoring”) and shall submit to Roszdravnadzor, annually no later than February 1, for a period of three years beginning with the year following the year of state registration of the medical device, electronic clinical monitoring reports through the automated information system of Roszdravnadzor in accordance with Annex No. 2 to this Procedure.
At the proposal of the medical device circulation entity, Roszdravnadzor may extend the clinical monitoring period specified in the first paragraph of this Clause.
6. Clinical monitoring shall be aimed at collecting clinical data on the effectiveness and safety of the medical device when used for its intended purpose (hereinafter, “clinical data”) and shall be conducted in accordance with a plan containing the following information:
a) the objectives and tasks of clinical monitoring, taking into account the available clinical data, specific characteristics and risk factors associated with the medical device;
b) the clinical monitoring design, including the rationale for the methods of obtaining and statistically analyzing clinical data, the selection of the study population, inclusion and exclusion criteria, the minimum number of subjects in the study group, and the need to include comparator groups in the study.
7. For the purpose of evaluating the clinical monitoring report, Roszdravnadzor shall engage a federal state budgetary institution under the authority of Roszdravnadzor (hereinafter, the “expert institution”).
8. The clinical monitoring report shall be registered by Roszdravnadzor in the automated information system of Roszdravnadzor on the day of its receipt.
9. Upon receipt in the automated information system of Roszdravnadzor, the clinical monitoring report shall be automatically transmitted to the expert institution.
10. Within 120 business days from the date of receipt of the clinical monitoring report, the expert institution shall evaluate the clinical monitoring report and submit such evaluation to Roszdravnadzor.
11. If the clinical monitoring report is not submitted within the period specified in Clause 5 of this Procedure, Roszdravnadzor shall take the actions provided for in the second paragraph of subparagraph “i” of Clause 137 of the Rules for the State Registration of Medical Devices, approved by Resolution of the Government of the Russian Federation No. 1684 dated November 30, 2024, including making a decision to suspend the validity of the state registration of the medical device for 30 business days, commencing on the day following the expiry of the specified deadline.

ANNEX No. 1
to the Procedure for Reporting All Cases of Identification of Adverse Events at All Stages of the Circulation of the Relevant Medical Device in the Territory of the Russian Federation and in the Territories of Other States, approved by Order No. 541n of the Ministry of Health of the Russian Federation dated May 26, 2026

INFORMATION TO BE INCLUDED IN AN ADVERSE EVENT REPORT

1. Information about the medical device circulation entity submitting the adverse event report (hereinafter referred to as the “report”) and carrying out activities in the field of circulation of medical devices provided for by Part 3 of Article 38 of Federal Law No. 323-FZ dated November 21, 2011, “On the Fundamentals of Health Protection of Citizens in the Russian Federation” (hereinafter referred to as “Federal Law No. 323-FZ”) <1>, including an individual using the medical device, except for medical device circulation entities carrying out activities within the territory of the International Medical Cluster or within the territories of innovative scientific and technological centers (hereinafter referred to as “medical device circulation entities”):
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<1> Part 3 of Article 96 of Federal Law No. 323-FZ.

a) for a legal entity — full and abbreviated name (if applicable), including transliteration, organizational and legal form, taxpayer identification number (for persons who are residents of the Russian Federation), address of location, as well as telephone number and email address;
b) for an individual registered as an individual entrepreneur — surname, first name and patronymic (if applicable), details of the identity document, taxpayer identification number (for persons who are residents of the Russian Federation), residential address, as well as telephone number and email address;
c) for an individual — surname, first name and patronymic (if applicable), telephone number and email address.
2. Type of report (initial, subsequent).
3. Information about the medical device in respect of which an adverse event was identified <2>:
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<2> Paragraph 15 of Part 1 of Article 14 of Federal Law No. 323-FZ.

a) name of the medical device in accordance with the registration certificate for the medical device or the registry entry in the State Register of Medical Devices and Organizations (Individual Entrepreneurs) Engaged in the Manufacture and Production of Medical Devices (hereinafter referred to as the “Register”);
b) number and date of the registration certificate for the medical device or the registration number and date of state registration of the medical device;
c) model (brand, version) of the medical device, composition and accessories necessary for the use of the medical device (if applicable), in accordance with the registration certificate for the medical device or the registry entry in the Register;
d) class of potential risk of use of the medical device in accordance with the nomenclature classification of medical devices by class depending on the potential risk of their use <3>;
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<3> Order No. 4n of the Ministry of Health of the Russian Federation dated June 6, 2012, “On Approval of the Nomenclature Classification of Medical Devices” (registered by the Ministry of Justice of the Russian Federation on July 9, 2012, Registration No. 24852), as amended by Orders of the Ministry of Health of the Russian Federation No. 557n dated September 25, 2014 (registered by the Ministry of Justice of the Russian Federation on December 17, 2014, Registration No. 35201), No. 686n dated July 7, 2020 (registered by the Ministry of Justice of the Russian Federation on August 10, 2020, Registration No. 59225), and No. 364n dated June 24, 2025 (registered by the Ministry of Justice of the Russian Federation on August 5, 2025, Registration No. 83136).

e) type of medical device in accordance with the nomenclature classification of medical devices by type;
f) name and address of location of the manufacturer of the medical device in accordance with the registration certificate for the medical device or the registry entry in the Register;
g) batch (lot) number of the medical device or serial number(s) of the medical device;
h) quantity of medical devices in circulation held by the medical device circulation entity, indicating the batch (lot) numbers and serial number(s) in respect of which the adverse event was identified, in units (if available);
i) date of manufacture of the medical device (if available);
j) shelf life (operating life) of the medical device (if available);
k) supplier or seller of the medical device (as applicable):
for a legal entity — full and abbreviated name (if applicable), including transliteration, organizational and legal form, taxpayer identification number (for persons who are residents of the Russian Federation), address of location, as well as telephone number and email address;
for an individual registered as an individual entrepreneur — surname, first name and patronymic (if applicable), details of the identity document, taxpayer identification number (for persons who are residents of the Russian Federation), residential address, as well as telephone number and email address;
l) addresses of the premises where the medical device was stored (if applicable);
m) person who used the medical device (if applicable):
for a legal entity — full and abbreviated name (if applicable), including transliteration, organizational and legal form, taxpayer identification number (for persons who are residents of the Russian Federation), address of location, as well as telephone number and email address;
for an individual registered as an individual entrepreneur — surname, first name and patronymic (if applicable), details of the identity document, taxpayer identification number (for persons who are residents of the Russian Federation), residential address, as well as telephone number and email address;
for an individual — surname, first name and patronymic (if applicable), telephone number and email address;
n) country, name of the constituent entity of the Russian Federation (if the adverse event occurred within the territory of the Russian Federation), locality, and address where the adverse event occurred;
o) status of the medical device at the time of submission of the report (disposed of, continues to be used, placed in quarantine, returned to the supplier) (as applicable);
p) number of medical devices involved in the adverse event (if available).
4. Adverse event:
a) date of the adverse event;
b) for implantable medical devices:
• date of implantation (as applicable);
• date of explantation (as applicable);
• duration of implantation (as applicable);
c) identification of the adverse event in accordance with the Classification of Adverse Events <4>;
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<4> Part 1 of Article 96 of Federal Law No. 323-FZ.

d) description of the use of the medical device (initial use, repeated use, use of a single-use medical device, use of a multiple-use medical device, medical device after maintenance or repair, the problem was identified prior to use, other method of use) (as applicable);
e) outcome of the adverse event (threat to the health and/or life of the individual by whom and/or in respect of whom the medical device was directly used (hereinafter referred to as the “user”), unexpected deterioration of the user’s health condition, death of the user, disability of the user, no threat to the life and/or health of the user) (as applicable);
f) measures taken by the user to eliminate the adverse event;
g) description of the adverse event.
5. Data on the injured person:
a) injured person (physician, nurse, patient, staff member, other person);
b) initials of the injured person or a differentiating code of the injured person assigned by the medical device circulation entity submitting the report (as applicable, if there are several injured persons);
c) sex and age, weight, height (if information is available);
d) number of injured persons (if information is available).
6. Additional information (if available).

Annex No. 2
to the Procedure for Reporting All Cases of Identification of Adverse Events at All Stages of the Circulation of the Relevant Medical Device in the Territory of the Russian Federation and in the Territories of Other States, approved by Order No. 541n of the Ministry of Health of the Russian Federation dated May 26, 2026

CLINICAL MONITORING REPORT FOR A MEDICAL DEVICE

1. Information about the manufacturer of the medical device or the authorized representative of the manufacturer of a Class 3 medical device in terms of potential risk of use, as well as a Class 2b medical device implanted in the human body in terms of potential risk of use (hereinafter referred to as the “medical device”), submitting the clinical monitoring report for the medical device (hereinafter referred to as “clinical monitoring”):
a) for a legal entity — full and abbreviated name (if applicable), including transliteration, organizational and legal form, taxpayer identification number (for persons who are residents of the Russian Federation), address of location, as well as telephone number and email address;
b) for an individual registered as an individual entrepreneur — surname, first name and patronymic (if applicable), details of the identity document, taxpayer identification number (for persons who are residents of the Russian Federation), residential address, as well as telephone number and email address.
2. Clinical monitoring report number assigned by the manufacturer of the medical device or the authorized representative of the manufacturer of the medical device.
3. Information about the medical device in respect of which the clinical monitoring report has been submitted:
a) name of the medical device in accordance with the registration certificate for the medical device or the registry entry in the State Register of Medical Devices and Organizations (Individual Entrepreneurs) Engaged in the Manufacture and Production of Medical Devices (hereinafter referred to as the “Register”);
b) number and date of the registration certificate for the medical device or the registration number and date of state registration of the medical device;
c) model (brand, version) of the medical device, composition and accessories necessary for the use of the medical device (if applicable), in accordance with the registration certificate for the medical device or the registry entry in the Register;
d) class of potential risk of use of the medical device in accordance with the nomenclature classification of medical devices<1>;
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<1> Order No. 4n of the Ministry of Health of the Russian Federation dated June 6, 2012, “On Approval of the Nomenclature Classification of Medical Devices” (registered by the Ministry of Justice of the Russian Federation on July 9, 2012, Registration No. 24852), as amended by Orders of the Ministry of Health of the Russian Federation No. 557n dated September 25, 2014 (registered by the Ministry of Justice of the Russian Federation on December 17, 2014, Registration No. 35201), No. 686n dated July 7, 2020 (registered by the Ministry of Justice of the Russian Federation on August 10, 2020, Registration No. 59225), and No. 364n dated June 24, 2025 (registered by the Ministry of Justice of the Russian Federation on August 5, 2025, Registration No. 83136).

e) type of medical device in accordance with the nomenclature classification of medical devices;
f) name and address of location of the manufacturer of the medical device in accordance with the registration certificate for the medical device or the registry entry in the Register;
g) address(es) of the manufacturing site(s) in accordance with the documents contained in the registration dossier for the medical device;
h) batch (lot) number of the medical device or serial number(s) of the medical device (as applicable);
i) quantity of medical devices in circulation, indicating the batch (lot) numbers and serial number(s), in units (if available);
j) date of manufacture of the medical device (if available);
k) shelf life (operating life) of the medical device (if available);
l) expiry date of the warranty period, operating period, or service life established by the manufacturer of the medical device (as applicable, if available);
m) person using the medical device (as applicable):
for a legal entity — full and abbreviated name (if applicable), including transliteration, organizational and legal form, taxpayer identification number (for persons who are residents of the Russian Federation), address of location, as well as telephone number and email address;
for an individual registered as an individual entrepreneur — surname, first name and patronymic (if applicable), details of the identity document, taxpayer identification number (for persons who are residents of the Russian Federation), residential address, as well as telephone number and email address;
for an individual — surname, first name and patronymic (if applicable), telephone number and email address.
4. Information on clinical monitoring:
a) list of identified residual risks associated with the medical device;
b) summary information on identified adverse events <2> and measures taken based on the results of the investigation conducted in respect of the adverse events;
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<2> Paragraph 15 of Part 1 of Article 14 of Federal Law No. 323-FZ dated November 21, 2011, “On the Fundamentals of Health Protection of Citizens in the Russian Federation”.

c) objectives and tasks of clinical monitoring;
d) clinical monitoring design;
e) clinical data obtained during the reporting period in the territory of the Russian Federation, indicating the medical organization(s) where the medical device is used;
f) assessment of the clinical data obtained during the reporting period;
g) assessment of all clinical data obtained during the clinical monitoring period;
h) conclusion regarding the necessity (or absence of necessity) to amend the clinical monitoring plan;
i) conclusion regarding the necessity (or absence of necessity) to perform corrective actions concerning the safety of the medical device;
j) description of corrective actions concerning the safety of the medical device (if applicable);
k) conclusion (justification) regarding the clinical safety and effectiveness of the medical device;
l) proposal regarding the necessity (or absence of necessity) to extend the clinical monitoring period specified in Clause 5 of this Procedure;
m) additional information and comments (if applicable).

5. Publications concerning experience with the use of the medical device during the post-registration period (if applicable).