Russia
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.



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