Last week Mediteq Forum hosted another successful webinar with focus on the new requirements in the medical device regulation for the Eurasian Economic Union. Alexey Stepanov from Raifarm in Moscow talked about the new requirements, the transition period and practical implications on future registrations in the Eurasian region. The new regulation comes into force the 1st Jan 2022 and will among other things require stricter requirements on post market surveillance and local clinical trials for higher class devices. Alexey answered questions from the participants and clarified that it will be possible to place devices registered under the local regulations on the market as long as no significant changes are made.
Citations of the day:
"Very good presentation. Useful information received that can be used for future RA market strategies."
"Very good lecture!"
"That more and more countries are tightening the requirements regarding medical technology products. Today's key words are - Patience."
"Information on the registration of medical devices in the Eurasian Union."