Order No. 540n by the Ministry of Health of the Russian Federation

Order by the Ministry of Health of the Russian Federation no. 540n "On Approval of the Procedure for Monitoring the Safety of Medical Devices, with the Exception of Medical Devices Registered in accordance with International Treaties and Acts Constituting the Law of the Eurasian Economic Union", dated 26 May 2026

 

In accordance with Part 2 of Article 14, Part 5 of Article 96 of Federal Law no. 323-FZ dated 21 November 2011 "On Basics of Health Protection of the Citizens in the Russian Federation" and item 1 of the Regulations on the Ministry of Health of the Russian Federation, approved by Decree of the Government of the Russian Federation no. 608, dated 19 June 2012, I order:

1. To approve the attached Procedure for monitoring the safety of medical devices, with the exception of medical devices registered in accordance with international treaties and acts constituting the law of the Eurasian Economic Union.

2. To invalidate the Order by the Ministry of Health of the Russian Federation no. 980n "On Approval of the Procedure for Monitoring the safety of medical devices", dated 15 September 2020 (registered by the Ministry of Justice of the Russian Federation on November 2, 2020, registration no. 60697).

3. This order comes into force on September 1, 2026 and is valid until September 1, 2032.

 

Minister

M.A. Murashko

 

Registered by the Russian Ministry of Justice on May 29, 2026.

Registration number 86748

 

APPROVED by Order by the Ministry of Health of the Russian Federation no. 540n dated 26 May 2026

 

Procedure for Monitoring the Safety of Medical Devices, with the Exception of Medical Devices Registered in accordance with International Treaties and Acts Constituting the Law of the Eurasian Economic Union

 

1. The purpose of monitoring the safety of medical devices, with the exception of medical devices registered in accordance with international treaties and acts constituting the law of the Eurasian Economic Union, is to identify and prevent adverse events ^1.

2. Monitoring the safety of medical devices, with the exception of medical devices registered in accordance with international treaties and acts constituting the law of the Eurasian Economic Union (hereinafter referred to as medical devices), includes the collection, processing, registration and analysis of information, including information received from the entities providing the circulation of medical devices, as well as individuals, using medical devices, based on:

a) reports of adverse events in the use of medical devices received in accordance with the requirements of the Reporting Procedure for 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 (hereinafter, respectively, reports of adverse events, adverse events, Reporting Procedure);

b) information provided by the Reporting Procedure transmitted by software using artificial intelligence technologies, which is a medical device with a built-in function of automatic transmission of such information to the automated information system of Roszdravnadzor ³;

c) reports on clinical monitoring of medical devices in order to confirm the safety and clinical efficacy in the use of medical devices of potential risk class 3, as well as implantable medical devices of potential risk class 2b, received from manufacturers of medical devices (an authorized representative of the manufacturer (producer);

d) information provided by the manufacturer (producer) of a medical device (his authorized representative) or a person who imports medical devices into the territory of the Russian Federation ⁴.

3. Roszdravnadzor shall involve a federal state budgetary institution under the jurisdiction of Roszdravnadzor (hereinafter referred to as the expert institution) in conducting safety monitoring.

4. Entities providing the circulation of medical devices, including individuals using medical devices, provide the manufacturer (producer) of a medical device or an authorized representative of the manufacturer (producer) of a medical device with access to a medical device with which an adverse event has occurred, for the purpose of conducting an investigation and other measures aimed at preventing harm to life and (or) health of citizens and medical workers related to the use of a medical device.

5. Entities providing the circulation of medical devices (with the exception of individuals who use medical devices), by local acts adopted within the framework of their activities, determine the procedure for collecting information in order to ensure the safe use of medical devices and appoint an official responsible for organizing this work (hereinafter referred to as the responsible official).

6. The duties of the responsible official include:

a) preparation and sending of reports on adverse events to Roszdravnadzor;

b) monitoring of Roszdravnadzor information letters posted on the official website on the Internet;

c) carrying out measures aimed at preventing harm to the life and (or) health of citizens and medical workers related to the use of medical devices involved in adverse events;

d) consideration of adverse events in the use of medical devices, monitoring the consequences of adverse events and timely notification to Roszdravnadzor.

7. The information specified in subitems "a" - "b" of item 2 of this Procedure, after being entered into the automated information system of Roszdravnadzor, is automatically transmitted to an expert institution.

8. Within three working days from the date of receipt of the information specified in subitems "a" and "b" of item 2 of this Procedure, the expert institution shall assess the presence of a causal relationship between the use of a medical device and the development of identified adverse events, as well as the presence of indications about the risk of the identified adverse events in the instructions for use or operating instructions of a medical device, and submits such an assessment to Roszdravnadzor.

9. Roszdravnadzor, within seven working days from the date of receipt of the notification of an adverse event, taking into account the assessment provided for in item 8 of this Procedure, notifies, through the automated information system of Roszdravnadzor, the manufacturer (producer) of a medical device or an authorized representative of the manufacturer (producer) of a medical device about the receipt of a notification of an adverse event and the need to provide information about the adverse event (hereinafter referred to as information about an adverse event).

10. The manufacturer (producer) of a medical device or an authorized representative of the manufacturer (producer) of a medical device, from the date of sending by Roszdravnadzor the notification provided for in item 9 of this Procedure, submits to Roszdravnadzor information about an adverse event through the automated information system of Roszdravnadzor:

a) [u31] within ten working days: the information provided for in items 1–3 of this Procedure and in paragraphs 2–4 of subitem "b" of item 11 of this Procedure;

b) within a period not exceeding thirty working days - in full the information provided for in item 11 of this Procedure.

11. Information about an adverse event includes:

a) information about the entities providing the circulation of medical devices, carrying out the types of activities provided for in Part 3 of Article 38 of Federal Law no. 323-FZ, as well as the individual who sent information about the adverse event:

legal entity - full and abbreviated (if any) names (with transliteration), organizational and legal form, taxpayer identification number (for persons who are residents of the Russian Federation), location address, as well as telephone number and e-mail address;

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

b) information about the medical device in respect of which an adverse event has been identified:

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 organizations (individual entrepreneurs) engaged in the manufacture and production of medical devices (hereinafter - the Register);

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

the model (label, version) of the medical device, the composition and accessories necessary for the use of the medical device (if any), in accordance with the registration certificate for the medical device or the registry entry in the Registry;

the class of potential risk of using a medical device in accordance with the nomenclature classification of medical devices;

type of medical device in accordance with the nomenclature classification of medical devices;

the name and location address 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;

the address (addresses) of the location (locations) of the production site (production sites) in accordance with the documents contained in the registration dossier for a medical device;

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

the number of medical devices in circulation (indicating the serial (batches) numbers, the factory number(s) for which the adverse event was detected, in units (if available);

date of manufacture (production) of the medical device (if available);

period of validity (exploitation) of the medical device (if available);

the end date of the warranty period, exploitation period, and service period set by the manufacturer (producer) of the medical device (as applicable, if available);

c) additional information:

the code of the adverse event according to the Classification of Adverse Events;

the number(s) of the adverse event report(s) for which information about the adverse event is provided;

preliminary results of the investigation of the adverse event by the manufacturer (producer) of a medical device or an authorized representative of the manufacturer (producer) of a medical device;

corrective actions performed by the manufacturer (producer) of a medical device or an authorized representative of the manufacturer (producer) of a medical device and the timing of their implementation;

the results of the investigation of the manufacturer (producer) of a medical device or an authorized representative of the manufacturer (producer) of a medical device;

the number of similar adverse events involving a medical device or a similar medical device of another manufacturer (producer) of a medical device, and a similar identification of the adverse event in accordance with the Classification of adverse events known to the manufacturer (producer) of the medical device or an authorized representative of the manufacturer (producer) of the medical device;

recommendations of the manufacturer(s) of the medical device or an authorized representative of the manufacturer(s) of the medical device on further handling of the medical device for users.

12. The expert institution, within forty working days from the date of receipt of the notification of an adverse event, prepares and sends an expert position to Roszdravnadzor.

13. Based on the results of the review and analysis of the information specified in item 2 of this Procedure, information about an adverse event, as well as the expert position of the expert institution, Roszdravnadzor shall make one of the following decisions within ten working days from the date of receipt of information about the adverse event and the expert position of the expert institution:

a) on carrying out control (supervisory) measures in accordance with Federal Law no. 248-FZ "On State Control (Supervision) and Municipal Control in the Russian Federation", dated 31 July 2020, and the Regulation on Federal State Control (Supervision) over the Circulation of Medical Devices, approved by the Decree of the Government of the Russian Federation no. 1066 "On Federal State Control (Supervision) over the circulation of medical Devices", dated 30 June 2021, (hereinafter referred to as control (supervisory) Measures), and suspension of use:

of a medical device, if the information specified in subitems "a" and "b" of item 2 of this Procedure has been received in relation to two or more of its models (labels, versions);

of models (labels, versions) of a medical device, if the information specified in subitems "a" and "b" of item 2 of this Procedure has been received in relation to two or more batches (series) of a medical device of the same model (label, version);

of a batch or series of a medical device, if the information specified in subitems "a" and "b" of item 2 of this Procedure has been received in relation to a batch or series of a medical device;

b) on the implementation of control (supervisory) measures;

c) on the absence of grounds for carrying out control (supervisory) measures.

14. If an adverse event has led to death, serious injury to health, permanent disability, or there was a threat of death or serious injury to health, Roszdravnadzor shall make the decisions specified in subitems "a" or "b" of item 13 of this Procedure before receiving information about the adverse event, as well as receiving and analyzing information specified in subitems "c" and "d" of item 2 of this Procedure.

15. The decision to withdraw a medical device from circulation is made based on the results of federal state control (supervision) over the circulation of medical devices.

16. Revocation of Roszdravnadzor decisions provided for in the paragraphs 2-4 of subitem "a" of item 13 of this Procedure, if, during control (supervisory) measures, the absence of samples of a medical device is revealed for selection and subsequent examination of the quality, effectiveness and safety of a medical device, is carried out by Roszdravnadzor based on the results of consideration of the results of medical device tests conducted in the laboratory, accredited in the national accreditation system, provided by the manufacturer (producer) of a medical device or an authorized representative of the manufacturer (producer) of a medical device.

17. Information on the decisions of Roszdravnadzor specified in items 13 and 15 of this Procedure is posted on the official website of Roszdravnadzor on the Internet in compliance with the restrictions established by the legislation of the Russian Federation on personal data, commercial and (or) state secrets, and (or) other legally protected secrets.

 

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¹ Item 15 of Part 1 of Article 14 of Federal Law no. 323-FZ "On the Fundamentals of Health Protection in the Russian Federation", dated 21 November 2011 (hereinafter - Federal Law no. 323-FZ).

² Part 3 of Article 96 of Federal Law no. 323-FZ.

³ Item 87 of the Rules for State Registration of Medical Devices, approved by Order by the Government of the Russian Federation no. 1684 dated 30 November 2024.

⁴ Part 3of Article 96of Federal Law no. 323-FZ.