Russia
General country-specific regulatory information is provided on this page. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, free of charge, to expedite the preparation of your medical device or IVD registration application. 
 
REGULATORY AUTHORITY: Medical devices are regulated by the Roszdravnadzor, the Russian healthcare and social development agency.

CLASSIFICATION SYSTEM: Medical devices are classified according to the EU risk-based model into Classes I, IIa, IIb and III.

TIMEFRAME: The registration process ranges from 8 months for Class I devices to 16 months for Class III devices.

LICENSE VALIDITY: Licenses issued in Russia do not expire.    

AUTHORIZED REPRESENTATIVE: A local authorized representative is required to register medical devices in Russia.

Last updated on January 10, 2018.



Interested in obtaining fast market approval for your medical device or IVD in Russia? REQUEST A FREE QUOTE>

For more information on registration in Russia, check out the following articles on our blog:
Country at a Glance: Russia
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