Order No. 540n dated 26 May, 2026 by the Ministry of Health of the Russian Federation
MINISTRY OF HEALTH
OF THE RUSSIAN FEDERATION
Order No. 540n dated 26 May 2026
On Approval of the Procedure for Monitoring the Safety of Medical Devices, Except for Medical Devices Registered in Accordance with International Treaties and Acts Constituting the Law of the Eurasian Economic Union
Registered with the Ministry of Justice of Russia on 29 May 2026, Registration No. 86748
Pursuant to Part 2 of Article 14 and Part 5 of Article 96 of Federal Law No. 323-FZ dated 21 November 2011, “On the Fundamentals of Health Protection of Citizens in the Russian Federation,” and Clause 1 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 19 June 2012, I hereby order:
1. To approve the attached Procedure for Monitoring the Safety of Medical Devices, except for medical devices registered in accordance with international treaties and acts constituting the law of the Eurasian Economic Union.
2. To repeal Order No. 980n of the Ministry of Health of the Russian Federation dated 15 September 2020, “On Approval of the Procedure for Monitoring the Safety of Medical Devices,” registered with the Ministry of Justice of the Russian Federation on 2 November 2020, Registration No. 60697.
3. This Order shall enter into force on 1 September 2026 and shall remain in effect until 1 September 2032.
Minister
M.A. MURASHKO
Approved by
Order No. 540n of the Ministry of Health
of the Russian Federation
dated 26 May 2026
PROCEDURE
for Monitoring the Safety of Medical Devices, Except for 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, except for 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>.
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<1> Clause 15 of Part 1 of Article 14 of Federal Law No. 323-FZ dated 21 November 2011 “On the Fundamentals of Health Protection of Citizens in the Russian Federation” (hereinafter, Federal Law No. 323-FZ).
2. Safety monitoring of medical devices, except for medical devices registered in accordance with international treaties and acts constituting the law of the Eurasian Economic Union (hereinafter, medical devices), includes the collection, processing, recording and analysis of information, including information received from entities engaged in the circulation of medical devices and from individuals using medical devices, based on:
a) adverse event reports concerning the use of medical devices received in accordance with the requirements of the Procedure for Reporting All Cases of Identification of Adverse Events at All Stages of Circulation of the Relevant Medical Device in the Territory of the Russian Federation and the Territories of Other States <2> (hereinafter, respectively, adverse event reports, adverse events and the Reporting Procedure);
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<2> Part 3 of Article 96 of Federal Law No. 323-FZ.
b) information provided for by the Reporting Procedure and transmitted by software using artificial intelligence technologies, where such software is a medical device with an integrated function for automatic transmission of such information to the automated information system of Roszdravnadzor; <3>
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<3> Clause 87 of the Rules for State Registration of Medical Devices approved by Resolution of the Government of the Russian Federation No. 1684 dated 30 November 2024.
c) clinical monitoring reports for medical devices intended to confirm safety and clinical performance when medical devices classified as potential risk class 3 are used, as well as implantable medical devices classified as potential risk class 2b, received from medical device manufacturers (manufacturers’ authorized representatives);
d) information submitted by the medical device manufacturer or its authorized representative, or by a person importing medical devices into the territory of the Russian Federation. <4>
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<4> Part 3.1 of Article 96 of Federal Law No. 323-FZ.
3. Roszdravnadzor shall engage a federal state budgetary institution under the authority of Roszdravnadzor to conduct safety monitoring (hereinafter, the expert institution).
4. Entities engaged in the circulation of medical devices, including individuals using medical devices, shall provide the medical device manufacturer or the manufacturer’s authorized representative with access to the medical device associated with an adverse event for the purposes of conducting an investigation and other measures aimed at preventing harm to the life and/or health of citizens and healthcare professionals associated with the use of the medical device.
5. Entities engaged in the circulation of medical devices (except for individuals using medical devices) shall, by internal acts adopted within the scope of their activities, establish procedures for collecting information to ensure the safe use of medical devices and appoint an official responsible for organizing this work (hereinafter, the responsible official).
6. The responsibilities of the responsible official shall include:
a) preparing and submitting adverse event reports to Roszdravnadzor;
b) monitoring information letters issued by Roszdravnadzor and posted on its official website on the Internet;
c) conducting measures aimed at preventing harm to the life and/or health of citizens and healthcare professionals associated with the use of medical devices involved in adverse events;
d) recording adverse events occurring during the circulation of medical devices, monitoring the consequences of adverse events, and promptly notifying Roszdravnadzor.
7. The information specified in subparagraphs “a” and “b” of Clause 2 of this Procedure shall, upon receipt by the Roszdravnadzor automated information system, be automatically transmitted to the expert institution.
8. Within three business days from the date of receipt of the information specified in subparagraphs “a” and “b” of Clause 2 of this Procedure, the expert institution shall assess whether there is a causal relationship between the use of the medical device and the occurrence of the identified adverse events, as well as whether the instructions for use or operating manual of the medical device contain indications of the risk of occurrence of the identified adverse events, and shall submit such assessment to Roszdravnadzor.
9. Within seven business days from the date of receipt of an adverse event report, taking into account the assessment provided for in Clause 8 of this Procedure, Roszdravnadzor shall, through the Roszdravnadzor automated information system, notify the medical device manufacturer or the manufacturer’s authorized representative of receipt of the adverse event report and the need to submit information on the adverse event (hereinafter, adverse event information).
10. From the date on which Roszdravnadzor sends the notification provided for in Clause 9 of this Procedure, the medical device manufacturer or the manufacturer’s authorized representative shall submit adverse event information to Roszdravnadzor through the Roszdravnadzor automated information system:
a) within a period not exceeding ten business days — the information provided for in Clauses 1–3 of this Procedure and paragraphs two to four of subparagraph “c” of Clause 11 of this Procedure;
b) within a period not exceeding thirty business days — the information provided for in full by Clause 11 of this Procedure.
11. Adverse event information shall include:
a) information on the entity engaged in the circulation of medical devices carrying out the activities provided for in Part 3 of Article 38 of Federal Law No. 323-FZ, as well as on the individual who submitted the adverse event information:
legal entity — full and abbreviated names (if applicable), with transliteration, legal form, taxpayer identification number (for persons that are residents of the Russian Federation), registered address, telephone number and email address;
individual or individual registered as an individual entrepreneur — surname, first name and patronymic (if applicable), details of the identity document, taxpayer identification number (for persons that are residents of the Russian Federation), residential address, telephone number and email address;
b) information on the medical device in relation to which the adverse event was identified:
name of the medical device as stated in the medical device registration certificate 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);
number and date of the medical device registration certificate or the registration number and date of state registration of the medical device;
model (mark, version) of the medical device, its configuration and accessories necessary for use of the medical device (if applicable), as stated in the medical device registration certificate or the registry entry in the Register;
medical device potential risk class in accordance with the nomenclature classification of medical devices;
type of medical device in accordance with the nomenclature classification of medical devices;
name and registered address of the medical device manufacturer as stated in the medical device registration certificate or the registry entry in the Register;
address(es) of the manufacturing site(s) in accordance with the documents contained in the medical device registration dossier;
medical device lot/batch number or serial number(s), as applicable;
number of medical devices in circulation (with indication of lot/batch and serial number(s)) in relation to which the adverse event was identified, in units (if applicable);
date of manufacture of the medical device (if applicable);
expiry date (service life) of the medical device (if applicable);
date of expiry of the warranty period, operating period or service life established by the medical device manufacturer, as applicable (if applicable);
c) additional information:
adverse event code in accordance with the Adverse Event Classification;
number(s) of the adverse event report(s) in relation to which the adverse event information is submitted;
preliminary results of the investigation by the medical device manufacturer or the manufacturer’s authorized representative of the adverse event that occurred;
corrective actions taken by the medical device manufacturer or the manufacturer’s authorized representative and the timelines for their implementation;
results of the investigation by the medical device manufacturer or the manufacturer’s authorized representative;
number of similar adverse events involving the medical device or a similar medical device manufactured by another manufacturer, with similar adverse event identification in accordance with the Adverse Event Classification, known to the medical device manufacturer or the manufacturer’s authorized representative;
recommendations of the medical device manufacturer or the manufacturer’s authorized representative to users concerning further circulation of the medical device.
12. Within forty business days from the date of receipt of an adverse event report, the expert institution shall prepare and submit an expert opinion to Roszdravnadzor.
13. Based on the review and analysis of the information specified in Clause 2 of this Procedure, the adverse event information, and the expert opinion of the expert institution, Roszdravnadzor shall, within ten business days from the date of receipt of the adverse event information and the expert opinion of the expert institution, make one of the following decisions:
a) to conduct control (supervisory) measures in accordance with Federal Law No. 248-FZ dated 31 July 2020 “On State Control (Supervision) and Municipal Control in the Russian Federation” and the Regulation on Federal State Control (Supervision) over the Circulation of Medical Devices approved by Resolution of the Government of the Russian Federation No. 1066 dated 30 June 2021 “On Federal State Control (Supervision) over the Circulation of Medical Devices” (hereinafter, control (supervisory) measures), and to suspend the use of:
the medical device, if the information specified in subparagraphs “a” and “b” of Clause 2 of this Procedure has been received in relation to two or more of its models (brands, versions);
the model (brand, version) of the medical device, if the information specified in subparagraphs “a” and “b” of Clause 2 of this Procedure has been received in relation to two or more lots (batches) of the medical device of the same model (brand, version);
the lot or batch of the medical device, if the information specified in subparagraphs “a” and “b” of Clause 2 of this Procedure has been received in relation to a lot or batch of the medical device;
b) to conduct control (supervisory) measures;
c) that there are no grounds for conducting control (supervisory) measures.
14. If an adverse event resulted in death, serious harm to health, permanent disability, or involved a threat of death or serious harm to health, Roszdravnadzor shall make the decisions specified in subparagraphs “a” or “b” of Clause 13 of this Procedure before receiving the adverse event information and before receiving and analyzing the information specified in subparagraphs “c” and “d” of Clause 2 of this Procedure.
15. A decision to withdraw a medical device from circulation shall be made based on the results of federal state control (supervision) over the circulation of medical devices.
16. Roszdravnadzor shall revoke the decisions provided for in paragraphs two to four of subparagraph “a” of Clause 13 of this Procedure if, during control (supervisory) measures, it is established that no medical device samples are available for sampling and subsequent examination of the quality, effectiveness and safety of the medical device, based on its review of the medical device test results submitted by the medical device manufacturer or the manufacturer’s authorized representative, where such tests were conducted by a laboratory accredited within the national accreditation system.
17. Information on the decisions of Roszdravnadzor specified in Clauses 13 and 15 of this Procedure shall be published on the official website of Roszdravnadzor on the Internet, subject to the restrictions established by the legislation of the Russian Federation concerning personal data, commercial and/or state secrets, and/or other legally protected secrets.