So, it happened!
The Eurasian Economic Commission has put forward a reasonable and logical proposal to postpone the
expiration date of national Registration Certificates for medical devices. (We remind you that under
current legislation, all medical devices registered in the EAEU member countries had to undergo a new
registration procedure under the EAEU standards before December 31, 2021, or to become invalid from
January 1, 2022).
Now they are talking about extending the transitional period for the re-registration of medical devices
with state certification in their country until December 31, 2026
Until December 31, 2021, the manufacturer will have the right to choose – medical devices will be
registered both according to the rules of the EAEU and according to national rules.
In this case, medical devices with national Registration Certificate will be circulated on the national
market until the expiration of the validity of the Registration Certificate, or indefinitely, if current
certificate is issued indefinitely.
The final decision to extend the re-registration deadline will be taken at the ECE meeting on September
3, 2019