The procedure and organization of inspections of medical devices production has been updated by the Government. The corresponding resolution No. 2517 of 29.12.2022 was published on the legal information portal. The document came into force on January 1, 2023.
The initial nine-month moratorium on inspections has been replaced by a transitional period when inspections are held on a voluntary basis. According to the document, the evaluation of the manufacturer’s quality management system for compliance with the requirements for the implementation, maintenance and evaluation of the quality management system of medical products, depending on the potential risk of their use, is not mandatory from January 1, 2023 to December 31, 2023.
If no assessment has been carried out during this period, then when submitting an application for state registration or for amendments to the registration dossier of the medical device that had potential risk of use class 2a (for medical devices manufactured in sterile form), 2b or 3, documents submitted in the registration dossier of the medical device must confirm that the manufacturer has production conditions and copies of certificates of compliance of the quality management system with requirements of GOST ISO 13485-2017 standard “Medical Products. Quality Management Systems. Requirements for regulatory purposes” or the corresponding international standard ISO 13485 (if available).
Also, manufacturers who have submitted applications for registration this year have to confirm the implementation of a quality management system by undergoing an initial inspection of production within three years from the date of registration of such medical products, respectively, in accordance with the procedure provided for unscheduled inspections.
It is clarified that there will be no inspection for manufacturers of medical devices that are in short supply. The exception was added to clause 3 of the rules, according to FV reports.
