🇷🇺Russia Medical Device Regulations

Rules for State Registration of Medical Devices

Current Russian rules for state registration of medical devices under Roszdravnadzor, including electronic submissions, review procedures, and registration-record requirements.

Legal Basis for Medical Device Circulation and Registration

Establishes that medical devices may circulate in Russia only after state registration and provides the legal basis for registry, licensing, and market-control functions.

Medical Device Safety Monitoring Requirements

Requires safety monitoring for medical devices in circulation to identify adverse reactions, unexpected interactions, and circumstances that may threaten patients or healthcare workers.