Registration of medical devices

Registration of medical devices is a state procedure aimed at allowing the release of high—quality and safe products to the Russian market.

Includes the following list of services provided:

initial consultation;
preparation of a set of registration dossiers in accordance with the Decree of the Government of the Russian Federation of 27.12.2012 N 1416 (ed. of 24.11.2020) "On approval of the Rules of state registration of medical devices";
organization, support of tests and research, examination of the result;
support in Roszdravnadzor in case of controversial issues, elimination of comments, appeal of illegal decisions of experts.