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.
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...
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The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.
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