Obtaining market authorization to sell your medical device in the Russian Federation requires approval from the Federal Service for Control in Healthcare and Social Development (Roszdravnadzor).
Device approvals in Russia depend on tests to demonstrate safety, efficiency, and quality. Testing must be performed by Roszdravnadzor-accredited facilities in Russia; similar testing by foreign entities is not accepted.
Medical device market approval in Russia is more accessible with an experienced regulatory partner. The Emergo Russia office has the expertise to help you determine if you should pursue market approval for your device.
Emergo's worldwide network of consultants, industry contacts and regulatory sources allows us to provide incisive analysis of multiple medical device markets, including Russia.
Our Global Regulatory Overview report service on Russia provides in-depth coverage of the following topics: