Registration Dossier Requirements
What documents must be included in a Russian medical device registration dossier under Government Decree No. 1684 and MOH Order No. 11.
Labelling & IFU Requirements
Russian labelling requirements for medical devices — mandatory Russian language, Cyrillic script, required label elements, EAC marking, and IFU obligations under MOH Order No. 11 and Decree No. 1684.
Risk Management (GOST R ISO 14971)
Risk management requirements for medical devices in Russia — GOST R ISO 14971 and how the risk file supports registration.