Order №368n
MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION
ORDER
dated 17 July 2023 N 368n
ON APPROVAL OF THE INDICATORS OF THE RISK OF VIOLATION OF MANDATORY REQUIREMENTS USED BY THE FEDERAL SERVICE FOR SURVEILLANCE IN HEALTHCARE WHEN EXERCISING FEDERAL STATE CONTROL (SUPERVISION) OVER THE CIRCULATION OF MEDICAL DEVICES
(as amended by Orders of the Ministry of Health of Russia dated 19.03.2025 N 135n,
dated 17.04.2025 N 218n)
In accordance with clause 1 of part 10 of Article 23 of Federal Law dated 31 July 2020 N 248-FL “On State Control (Supervision) and Municipal Control in the Russian Federation”, clause 1 of the Regulations on the Ministry of Health of the Russian Federation, approved by Resolution of the Government of the Russian Federation dated 19 June 2012 N 608 <1>, I hereby order:
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<1> Clause 3 of the Regulations on Federal State Control (Supervision) over the Circulation of Medical Devices, approved by Resolution of the Government of the Russian Federation dated 30 June 2021 N 1066.
1. To approve the attached list of indicators of the risk of violation of mandatory requirements used by the Federal Service for Surveillance in Healthcare when exercising federal state control (supervision) over the circulation of medical devices.
2. To declare no longer in force Order of the Ministry of Health of the Russian Federation dated 24 May 2021 N 503н “On Approval of the Indicator of the Risk of Violation of Mandatory Requirements Used by the Federal Service for Surveillance in Healthcare When Exercising Federal State Control (Supervision) over the Circulation of Medical Devices” (registered by the Ministry of Justice of the Russian Federation on 29 June 2021, registration N 64000).
Minister
M.A.MURASHKO
Approved
by Order of the Ministry of Health
of the Russian Federation
dated 17 July 2023 N 368н
LIST
OF INDICATORS OF THE RISK OF VIOLATION OF MANDATORY REQUIREMENTS,
USED BY THE FEDERAL SERVICE FOR SURVEILLANCE IN
HEALTHCARE WHEN EXERCISING FEDERAL
STATE CONTROL (SUPERVISION)
OVER THE CIRCULATION OF MEDICAL DEVICES
List of amending documents
(as amended by Orders of the Ministry of Health of Russia dated 19.03.2025 N 135n,
dated 17.04.2025 N 218n)
-
No longer in force. – Order of the Ministry of Health of Russia dated 17.04.2025 N 218n.
2. Receipt by the licensing authority within one year of an application for the granting of a licence to carry out activities involving the maintenance of medical devices (except where maintenance is carried out to meet the own needs of a legal entity or an individual entrepreneur, as well as where maintenance is carried out on medical devices with a low degree of potential risk associated with their use) (hereinafter – activities involving the maintenance of medical devices) or for amendments to the register of licences to carry out activities involving the maintenance of medical devices (hereinafter – the register of licences) from a licence applicant (licensee) carrying out activities involving the maintenance of medical devices using measuring instruments, technical means and equipment belonging to it by right of ownership or on another lawful basis providing for the right of possession and the right of use, having identifying features (name, brand, modification, factory (serial) number, manufacturer), also belonging by right of ownership or on another lawful basis providing for the right of possession and the right of use to another licensee (licensees) located in another constituent entity of the Russian Federation.
3 – 4. No longer in force. – Order of the Ministry of Health of Russia dated 17.04.2025 N 218n.
5. Non-receipt from the developer or manufacturer (producer) of a medical device, or the authorised representative of the manufacturer (producer) of a medical device, or a person importing a medical device into the Russian Federation for the purpose of its state registration, of a repeat application for amendments to the documents contained in the registration dossier for the medical device, within 180 working days from the date on which the Federal Service for Surveillance in Healthcare adopts, in accordance with international treaties and acts constituting the law of the Eurasian Economic Union or acts of the Government of the Russian Federation issued pursuant to parts 4 and 5.1 of Article 38 of Federal Law dated 21 November 2011 N 323-FL “On the Fundamentals of Health Protection of Citizens in the Russian Federation”, the corresponding decision to refuse to make amendments to the registration dossier or to return the application for amendments and documents, or to discontinue further consideration of the application for amendments to the documents contained in the registration dossier, provided that such medical device is offered for sale, including by remote means.
(clause 5 introduced by Order of the Ministry of Health of Russia dated 19.03.2025 N 135n)