Medical device registration certificate - GBSI - Global Business Service Information
An official document permitting transportation, selling and use of any medical devices in the territory of the Russian Federation. Such registration certificate can only be issued by a state body – Roszdravnadzor (Russian Federal Service for Supervision in Healthcare), after various trials are passed. Receiving such document requires several steps: preparation of a registration dossier (includes development or elaboration of all technical documents, descriptions, similar products use practices), passing the trials (bacteriological, technical, clinical) and filing the documents to the Authority. The issuance procedure time for such document is 1 year and up, but it is issued once to remain in force without limit of time.