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.
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