Further Transition Period Mooted As Eurasian Device System Comes Into Force To Little Fanfare
After a five-year regulatory transition, access to the Eurasian Economic Union market for new medtech products must now take place via the EAEU system only. But having got off to a slow start, further system transitional measures are now under discussion.
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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.
There are just 4.5 months left until the new harmonized Eurasian Economic Union medtech system becomes mandatory, signifying major changes in regional market access. EAEU member Russia is meanwhile strengthening its post-market medtech controls.
Environmental demands, the evolution of care models, new delivery technologies and AI tools are influencing how medtechs must approach innovation.