14 February 2019
The Ministry of Health of the Russian Federation supported the decision of Roszdravnadzor to take control over the medical devices production sites. The subject of future inspections will be compliance by enterprises with the quality management system.
The document developed by the Ministry of Health was published on the Federal portal.
The authors of the project explain that the empowerment of Roszdravnadzor is connected with the harmonization of legislation of the countries — participants of the Eurasian Economic Union. An agreement on common principles and rules for the circulation of medical devices implies a requirement for the implementation and maintenance of quality management system (ISO) for such products, depending on the potential risk of their use.
Accordingly, inspectors will check medical devices manufacturers with a potential class of risk 2a (sterile products), 2b (increased risk) and 3 (high risk) during registration of such products. Roszdravnadzor will be able to involve third-party organizations in the inspection as well.
The public negotiation of the new piece of regulation will last until February 15, 2019.
According to the Deputy Head of Roszdravravnadzor Dmitry Pavlyukov, the new powers will allow the Federal Service «to go to the production sites of not just domestic, but also foreign manufacturers and make sure that, indeed, the medical products are produced on this site and that their quality meets the requirements.»