On January 1, 2023, a new procedure for checking the production of medical devices, approved by the Government, came into force. The corresponding order No. 2517 dated December 29, 2022 was published on the legal information portal.
According to the updated document, inspection of the quality management system in relation to its implementation, maintenance and evaluation will become optional for medical devices with a low level of potential risk. During the year, a ten-month moratorium will also be replaced by voluntary inspections as part of a transitional period.
If the assessment was not made within the specified timeframe, then the manufacturer who wants to register its medical device with the risk of using of class 2a (for sterile devices), 2b or 3, or make adjustments to the registration dossier, must attach to the application documents that confirm the compliance with the production conditions, as well as certificates of compliance with GOST ISO 13485-2017 or a similar international standard ISO 13485 for a quality management system.
In addition, it must be confirmed that the quality management system has been implemented through an initial production audit. The confirmation period is 3 years from the date of registration of medical devices. The procedure for such initial inspection is established by the procedure approved for unscheduled inspections.
Paragraph 3 of the new rules provides for exemption from inspection for manufacturers of medical devices listed as in short supply or deficiency. This list can be found on the website of the Federal Service for Surveillance in Healthcare.
For other devices, the requirements established in February 2022 will apply. The corresponding resolution is valid from September 1, 2022 to September 1, 2028. Authorized inspectors, in accordance with the procedure, are appointed organizations subordinate to the Federal Service for Surveillance in Healthcare.
It is also important to note that the minimum retention period for inspection records is ten years from the date of the inspection.