Advice To Companies Accessing The New Eurasian Union Market: ‘Choose Russia’

The Eurasian Union’s medical device regulatory system, many years in the planning, becomes mandatory in January 2022. But new amendments posted in late summer allow for national registrations to remain valid after the deadline. Moscow-based consultancy RegMT explains the background, and the likely path ahead.

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Russia and the four other regional markets in the Eurasian Economic Union, Kazakhstan, Belarus Kyrgyzstan and Armenia, have been preparing for the mandatory entry into force of the regional reference-country based system of harmonized medtech regulation, on 1 January 2022.

Coupled with a rush of national system regulatory compliance work for companies ahead of the transition deadline, the past year has been the heaviest in terms of the volume of...

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