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Flurry of Russian Medtech Regulatory System Proposals Keeps Manufacturers On Their Toes

 
• By Ashley Yeo

Russian medtech industry expert Alexey Stepanov reports an uptick in regulatory activity nationally in the final trimester of 2016. The catalyst seems to be the impending launch of the system of harmonization of medical device regulation within the regional Eurasian Economic Union (EAEU).

Kremlin

Russia's Ministry of Health issued draft proposals in several areas of medtech regulation during October 2016.

They would amend the key medical device instrument Resolution 1416 within Russian Federal Law No. 323-FZ, which are the texts that emerged from a revision and update of Russia's previous regulations. Resolution 1416 was issued in 2013 (Also see "Russia’s Medtech Revolution" - In Vivo, 11 April, 2014

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