Medical Device Registration and Approval in Russia

General country-specific regulatory information is provided on this page for medical device registration and approval in Russia. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Russia, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in 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.

For more information on Medical Device Registration in Russia, check out the following articles:

Country at a glance: Russia

 

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