Are medical devices difficult to register in Russia?

Question

Are medical devices difficult to register in Russia?

This question was asked as part of our webinar on Russia which can be found at:

http://opentoexport.com/webinars/beyond-the-eu-russia/

Answer

Really, this depends on the device. Typically, it is no more difficult to register in Russia than it is within the European Union. The Eurasian Economic Community to which Russia belongs actually adopted the English-language versions of the European Union’s treaties as its draft documents around which to develop its own treaty. Its long-term objective is to harmonise with European Union standards.

As of this year, Russia/EaEC accepts many tests conducted in the European Union as valid without requiring retesting.

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