Flurry of Russian Medtech Regulatory System Proposals Keeps Manufacturers On Their Toes
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).
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Russia's medtech regulatory agency Roszdravnadzor has received its share of criticism, but its performance has improved of late. New health ministry rules on technical file requirements have given the medtech industry additional cause for optimism.
Addressing pricing challenges for implantable devices, responding to a national localization drive and working with the Russian health-care products regulator Roszdravnadzor on market access issues for international companies are high priorities for IMEDA, Russia's International Medical Device Manufacturers Association. But, increasingly, another major focus is ensuring the stability of the local industry.
The much-anticipated Eurasian Economic Union (EAEU) was originally targeted to come into effect at the start of 2016, but more than year later, the five-member trading bloc has yet to be ratified by all nations. The Russian medtech industry is impatient for progress, but IMEDA's Sergey Kolosov sees some promising signs in recent developments.