State registration of medical device is a state procedure to ensure that only quality and safe medical devices are introduced into the Russian market.
Article 38, paragraph 4, of the Federal Law dated November 21, 2011 № 323-FZ “On Fundamentals of Healthcare of the Russian Federation Citizens” establishes that medical devices registered by an authorized federal executive body in accordance with the procedure, set by the Government of the Russian Federation are allowed for circulation on the territory of the Russian Federation.
The procedure of the state registration is approved by the Resolution of the Government of the Russian Federation dated by August 12, 2014 №1416 “Approval of regulation of the State Registration of Medical Devices”, the Administrative Regulation of the Federal Service on surveillance in healthcare in Terms of Provision of the State Service of Registration of Medical Devices approved by the Order of the Ministry of Health of the Russian Federation dated October 14, 2013 № 737н.
The definition “State registration of medical devices” includes:
- state registration of medical devices;
- making amendments to the registration certificates;
- issue of a duplicate of the registration certificates;
- making amendments to registration documents;
- replacement of the registration certificates;
- cancellation of state registration.