Order No. 541n by the Ministry of Health of the Russian Federation

Order by the Ministry of Health of the Russian Federation dated 26 May 2026 no. 541n "On approval of the Procedure for Reporting all cases of adverse events at all stages of the circulation of the relevant medical device in the territory of the Russian Federation and territories of other States" (Registered by the Ministry of Justice of the Russian Federation on 29 May 2026, reg. no. 86734)

 

 

Registered by the Ministry of Justice of the Russian Federation on 29 May 2026 reg. no. 86734

 

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

 

ORDER

dated 29 May 2026 no. 541n

 

ON THE APPROVAL OF THE PROCEDURE

for Reporting All Cases of Adverse Events

at All Stages of the Circulation of the Relevant Medical

Device in the Territory of the Russian Federation

and territories of other States

 

In accordance with item 15 of part 1 of Article 14, part 3 of Article 96 of the Federal Law dated 21 November 2011 no. 323-FZ “On the Fundamentals of Healthcare of Citizens of the Russian Federation” and subitem 5.2.192 of the Statute on the Ministry of Healthcare of the RF as approved by Decree of the Government of the RF dated 19 June 2012 no. 608, I hereby order:

1. To approve the attached Procedure for reporting all cases of adverse events at all stages of the circulation of the relevant medical device in the territory of the Russian Federation and the territories of other states.

2. To invalidate the order by the Ministry of Health of the Russian Federation dated 19 October 2020 no. 1113n "On Approval of the Procedure for reporting by the entities providing the circulation of medical devices on any adverse events not mentioned in the instructions for use or operating manual for the related medical device, adverse reactions during its usage, specific issues related to medical device interactions, and any other related findings which potentially may pose a threat to the life and health of patients and healthcare personnel using or operating medical devices (registered by the Ministry of Justice of the Russian Federation on 7 December 2020, reg. no. 61286).

This Order becomes effective from 01 September 2026 and is in force until 01 September 2032.

 

Minister

M.A. MURASHKO

 

 

 

 

 

APPROVED

By order of the Ministry of Healthcare

of the Russian Federation

dated 29 May 2026 no. 541n

 

 

Procedure

for Reporting All Cases of Adverse Events

at All Stages of the Circulation of the Relevant Medical

Device in the Territory of the Russian Federation

and territories of other States

 

1. Entities providing the circulation of medical devices engaged in the types of activities provided for in Part 3 of Article 38 of the Federal Law dated 21 November 2011 no. 323-FZ “On the Fundamentals of Healthcare of Citizens of the Russian Federation” (hereinafter referred to as Federal Law no. 323-FZ) <1>, including individuals who use medical devices, with the exception of entities providing the circulation of the medical device operating on the territory of an international medical cluster or on the territories of innovative scientific and technological centers (hereinafter referred to as - entities providing the circulation of medical devices), within twenty working days from the date of detection of an adverse event <2>, send to the Federal Service for Supervision of Healthcare through the automated information system of Roszdravnadzor a notification on an adverse event containing information in accordance with Appendix no. 1 to this Procedure.

--------------------------------

<1> Part 3 of Article 96 of the Federal Law no. 323-FZ.

<2> Item 15 of part 1 of Article 14 of the Federal Law no. 323-FZ.

 

2. The information indicated in the notification on an adverse event is confirmed by relevant documents, copies of which are attached to the notification on an adverse event (if available).

3. The notification on an adverse event is recorded in the section "Adverse events of medical devices" of the automated information system of Roszdravnadzor on the day of its receipt.

4. If additional information about the adverse event has become known to the entities providing the circulation of the medical device who sent the notification on the adverse event, it is sent to Roszdravnadzor by submitting a subsequent notification on the adverse event.

5. In relation to medical devices of potential risk class 3, as well as medical devices implanted into the human body of potential risk class 2b, in order to confirm safety and clinical efficacy in use, the manufacturer (producer) of the medical device or an authorized representative of the manufacturer (producer) of the medical device conducts clinical monitoring of the medical device (hereinafter referred to as - clinical monitoring) and annually, no later than February 1, for three years, starting from the year following the year of state registration of a medical device, submits to Roszdravnadzor in electronic form through the automated Roszdravnadzor information system reports on clinical monitoring of a medical device in accordance with Appendix no. 2 to this Procedure.

At the suggestion of the entities providing the circulation of the medical devices, the period of clinical monitoring specified in the first paragraph of this item may be extended by Roszdravnadzor.

6. Clinical monitoring is aimed at collecting clinical data on the effectiveness and safety of a medical device when used as intended (hereinafter referred to as clinical data) and is carried out in accordance with a plan that should contain the following information:

a) the goals and objectives of clinical monitoring, taking into account the available clinical data, specific features and risk factors associated with a medical device;

b) the scheme of clinical monitoring, including the justification of methods (ways) for obtaining and statistical analysis of clinical data, the selection of the study population, criteria for inclusion (exclusion) and the minimum number of subjects in the study group and the need to include comparison groups in the study.

7. To evaluate the clinical monitoring report, Roszdravnadzor engages a federal state budgetary institution under the jurisdiction of Roszdravnadzor (hereinafter referred to as the expert institution).

8. The Report on the Clinical Monitoring is registered by Roszdravnadzor in the automated information system of Roszdravnadzor on the day of its receipt.

9. The Report on the Clinical Monitoring is automatically transmitted to the expert institution after it is entered into the automated information system of Roszdravnadzor.

10. Within one hundred and twenty working days from the date of receipt of the Report on the Clinical Monitoring, the expert institution evaluates the Report on the Clinical Monitoring and submits its evaluation to Roszdravnadzor.

And. If the Report on the Clinical Monitoring is not submitted within the time period specified in item 5 of this Procedure, Roszdravnadzor shall take the actions provided for in the second paragraph of subitem "i" of item 137 of the Rules for State Registration of Medical Devices approved by the decree of the Government of the Russian Federation dated 30 November 2024 no. 1648, in particular, it makes a decision to suspend the state registration of a medical device for 30 working days from the day following the specified period.

 

 

 

 

 

Appendix no. 1

to the Procedure for Reporting

all cases

of adverse events at all stages

of the circulation of the relevant medical

device in the territory of the Russian

Federation and territories of other

States, approved by order

of the Ministry of Healthcare

of the Russian Federation

dated 29 May 2026 no. 541n

 

Information Contained in the Notification on an Adverse Event

 

1. Information about the entities providing the circulation of the medical device that sent the notification on the adverse event (hereinafter referred to as the notification), which carries out activities in the field of circulation of the medical device provided for in Part 3 of Article 38 of the Federal Law dated 21 November 2011 no. 323-FZ “On the Fundamentals of Healthcare of Citizens of the Russian Federation” (hereinafter referred to as Federal Law no. 323-FZ) <1>, including individuals who use medical devices, with the exception of entities providing the circulation of the medical device operating on the territory of an international medical cluster or on the territories of innovative scientific and technological centers (hereinafter referred to as - entities providing the circulation of medical devices):

--------------------------------

<1> Part 3 of Article 96 of the Federal Law no. 323-FZ.

 

a) for a legal entity - full and (if applicable) short  name (with transliteration), organizational legal form of the legal entity, taxpayer identification number (for residents of the Russian Federation), location address, as well as telephone number and e-mail address;

b) for an individual registered as an individual entrepreneur - the last name name, first name and patronymic (if applicable), the details of the identity document, the taxpayer identification number (for residents of the Russian Federation), the address of the place of residence, as well as the telephone number and e-mail address;

c) for an individual - last name, first name and patronymic (if applicable), phone number and e-mail address.

2. Type of Notification (primary, follow-up).

3. Information about the medical device in relation to which an adverse event has been identified <2>:

--------------------------------

<2> Item 15 of part 1 of Article 14 of the Federal Law no. 323-FZ.

 

a) the 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 Legal Entities or Individual Entrepreneurs engaged in the manufacture and production of medical devices (hereinafter - the Register);

b) the number and date of the registration certificate for a medical device or the registration number and date of state registration of a medical device;

c) the model (label, version) of the medical device, the 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 Registry;

d) the class of potential risk of using a medical device in accordance with the Nomenclature Classification of medical devices into classes depending on the potential risk of their use <3>;

--------------------------------

<3> Order by the Ministry of Health of the Russian Federation dated 6 June 2012 no 4n, On Approval of the Nomenclature Classification of Medical Devices (registered by the Ministry of Justice of the RF on 9 July, 2012, reg. no. 24852) as amended by the Orders of the Ministry of Health of the Russian Federation dated 25 September 2014 no. 557n (registered by the Ministry of Justice of the RF on 17 December 2014, reg, no. 35201), dated 7 July 2020 no 686n. (registered by the Ministry of Justice of the RF on 10 August 2020, reg, no. 59225), dated 24 June 2025 no 364n. (registered by the Ministry of Justice of the RF on 5 August 2025, reg, no. 83136).

 

e) the type of medical device in accordance with the Nomenclature Classification of Medical Devices by type;

f) the name and address of the location of the manufacturer (producer) of the medical device in accordance with the registration certificate for the medical device or the registry entry in the Registry;

g) batch (lot) number of the medical device or serial number (numbers) of the medical device;

h) number of medical devices in circulation (stating the serial number, lot numbers and batch numbers, factory numbers etc.), associated with the adverse event, in units (if applicable);

i) date of manufacture (production) of the medical device (if applicable);

j) expiry date or service life term of the medical device (if applicable);

k) supplier or seller of a medical device (as applicable):

for a legal entity - full and (if applicable) short  name (with transliteration), organizational legal form of the legal entity, taxpayer identification number (for residents of the Russian Federation), location address, as well as telephone number and e-mail address;

for an individual registered as an individual entrepreneur - the last name name, first name and patronymic (if applicable), the details of the identity document, the taxpayer identification number (for residents of the Russian Federation), the address of the place of residence, as well as the telephone number and e-mail address;

l) addresses of the premises used as storage for the medical device (if applicable);

m) the individual who carried out the application of the medical device (as applicable):

for a legal entity - full and (if applicable) short  name (with transliteration), organizational legal form of the legal entity, taxpayer identification number (for residents of the Russian Federation), location address, as well as telephone number and e-mail address;

for an individual registered as an individual entrepreneur - the last name name, first name and patronymic (if applicable), the details of the identity document, the taxpayer identification number (for residents of the Russian Federation), the address of the place of residence, as well as the telephone number and e-mail address;

for an individual - last name, first name and patronymic (if applicable), phone number and e-mail address;

n) country, name of the subject of the Russian Federation (if the adverse event occurred in the territory of the Russian Federation), settlement, address where the adverse event occurred;

o) the status of the medical device at the time of sending the notification (recycled, still in use, quarantined, returned to the supplier) (as applicable);

p) the number of medical devices involved in the adverse event (if applicable).

4. Adverse Ivent:

a) date on which the adverse event occurred;

b) for the implanted medical devices:

Date of implantation (as applicable);

Date of explantation (as applicable);

Length of implantation (as applicable);

c) identification of an adverse event according to the Classification of Adverse events <4>;

--------------------------------

<4> Part 1 of Article 96 of the Federal Law no. 323-FZ.

 

d) a description of usage of the medical device (initial, repeated, use of a single use medical device, multi-use medical device usage, medical device after maintenance or service; the issue was identified before the start of usage, other (as applicable);

e) the outcome of an adverse event (threat to the health and (or) life of an individual who used the medical device and (or) in respect of whom the medical device was directly used (hereinafter referred to as the user), unforeseen deterioration of the user's health, death of the user, disability of the user, the absence of the threat to the life and (or) health of the user (as applicable);

f) the measures taken by the user to eliminate the adverse event;

g) the description the adverse event.

5. Information about the injured individual:

a) the injured individual (doctor, nurse, patient, staff, other individual);

b) initials of the injured individual or the injured individual's differentiating code assigned by the entity providing the cerculation of the medical device who sent the notification (if applicable, if there are several injured individuals);

c) gender and age, weight, height (if available);

d) number of injured individuals (if available);

6. Additional information (if applicable).

 

 

 

 

 

Appendix no. 2

to the Procedure for Reporting

all cases

of adverse events at all stages

of the circulation of the relevant medical

device in the territory of the Russian

Federation and territories of other

States, approved by order

of the Ministry of Healthcare

of the Russian Federation

dated 29 May 2026 no. 541n

 

Report on the Clinical Monitoring of the medical device

 

1. Information about the manufacturer (producer) of a medical device or an authorized representative of the manufacturer (producer) of a medical device of potential risk class 3, as well as a medical device implanted in the human body of potential risk class 2b (hereinafter referred to as the medical device), who sent a Report on the Clinical Monitoring of the medical device (hereinafter referred to as Clinical Monitoring):

a) for a legal entity - full and (if applicable) short  name (with transliteration), organizational legal form of the legal entity, taxpayer identification number (for residents of the Russian Federation), location address, as well as telephone number and e-mail address;

b) for an individual registered as an individual entrepreneur - the last name name, first name and patronymic (if applicable), the details of the identity document, the taxpayer identification number (for residents of the Russian Federation), the address of the place of residence, as well as the telephone number and e-mail address.

2. The number of the Report on the Clinical Monitoring assigned by the manufacturer (producer) of the medical device or an authorized representative of the manufacturer (producer) of the medical device.

3. Information about the medical device in relation to which the Report on the Clinical Monitoring was provided:

a) the 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 Legal Entities or Individual Entrepreneurs engaged in the manufacture and production of medical devices (hereinafter - the Register);

b) the number and date of the registration certificate for a medical device or the registration number and date of state registration of a medical device;

c) the model (label, version) of the medical device, the 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 Registry;

d) class of risk of the medical device in accordance with the Nomenclature Classification of Medical Devices <1>;

--------------------------------

<1> Order by the Ministry of Health of the Russian Federation dated 6 June 2012 no 4n, On Approval of the Nomenclature Classification of Medical Devices (registered by the Ministry of Justice of the RF on 9 July, 2012, reg. no. 24852) as amended by the Orders of the Ministry of Health of the Russian Federation dated 25 September 2014 no. 557n (registered by the Ministry of Justice of the RF on 17 December 2014, reg, no. 35201), dated 7 July 2020 no 686n. (registered by the Ministry of Justice of the RF on 10 August 2020, reg, no. 59225), dated 24 June 2025 no 364n. (registered by the Ministry of Justice of the RF on 5 August 2025, reg, no. 83136).

 

e) type of the medical device in accordance with the Nomenclature Classification of Medical Devices

f) the name and address of the location of the manufacturer (producer) of the medical device in accordance with the registration certificate for the medical device or the registry entry in the Registry;

g) the address(es) of the location(s) of the production site(s) in accordance with the documents contained in the registration dossier for the medical device;

h) the serial (batch) number of the medical device or the factory number(s) of the medical device (if applicable);

i) the number of medical devices in circulation (indicating the serial numbers (batches), the factory number(s), in units (if applicable);

k) the date of manufacture (production) of the medical device (if applicable);

l) expiry date or service life term of the medical device (if applicable);

m) expiry date of the warranty period, service life, operational period, as set by the manufacturer (producer) of the medical device (if applicable, if available);

n) the individual who carries out the application of the medical device (as applicable):

for a legal entity - full and (if applicable) short  name (with transliteration), organizational legal form of the legal entity, taxpayer identification number (for residents of the Russian Federation), location address, as well as telephone number and e-mail address;

for an individual registered as an individual entrepreneur - the last name name, first name and patronymic (if applicable), the details of the identity document, the taxpayer identification number (for residents of the Russian Federation), the address of the place of residence, as well as the telephone number and e-mail address;

for an individual - last name, first name and patronymic (if applicable), phone number and e-mail address.

4. Information about the Clinical Monitoring:

a) a list of identified residual risks related to the medical device;

b) generalized information about the identified adverse events <2>, the measures taken based on the results of the investigation into the adverse events;

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<2> Item 15 of part 1 of Article 14 of the Federal Law no. 323-FZ “On the Fundamentals of Healthcare of Citizens of the Russian Federation”, dated 21 November 2011.

 

c) goals and objectives of the Clinical Monitoring;

d) scheme of the Clinical Monitoring;

e) clinical data obtained during the reporting period on the territory of the Russian Federation, indicating the medical organization(s) in which the medical device is used;

f) evaluation of clinical data obtained during the reporting period;

g) evaluation of all clinical data obtained during the period of the Clinical Monitoring;

h) conclusion on the need (or lack of need) to correct the plan of the Clinical Monitoring;

i) conclusion of the need (or lack of need) to implement any corrective actions related to the safety of the medical device;

j) description of corrective actions related to the safety of the medical device (if applicable);

k) conclusion (justification) on the safety and efficiency of the medical device;

l) suggestion on the need (or lack of need) to extend the cycle mentioned in item 5 of this Procedure of Clinical Monitoring;

m) additional information and comments (if applicable).

5. Publications on the experience of using a medical device in the post-registration period (if applicable).