The US FDA medical device classification scheme presents some unique challenges for new technology. With a system based on equivalence , manufacturers of new and...
Russia Medical Device and IVD Regulatory Strategy Report
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.
Let Emergo assist you in evaluating the Russian medical device regulatory framework as it applies to your device(s)
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:
- Regulatory background on Roszdravnadzor
- Product assessment and products grouping
- Authorized representation in Russia
- Medical device registration requirements
- Costs and timeframes
- Labeling and language requirements
- Regulatory roadmap for Russia