Cancellation of the registration certificate with regard to a medical device Russia

The registering authority decides to cancel the state registration of a medical device on the basis of paragraph 57 of Resolution of the Government of the Russian Federation No. 1416 dated 27 December 2012 “On Approval of the Rules for the State Registration of Medical Devices”.

There is no state fee for the revocation of a registration certificate.

At the same time, the manufacturer of a medical device or the organisation that imports the medical device into the territory of the Russian Federation, at least six months before the planned suspension or termination of the production of the medical devices or their import into the territory of the Russian Federation, shall notify this to the federal executive body that exercises the functions of control and surveillance in the field of health*.

*Federal Law No. 323-FZ dated 21 November 2011 “On the Basics of Protecting the Health of Citizens in the Russian Federation”, Article 38, Part 25 was introduced by Federal Law No. 64-FZ dated 26 March 2022.