EAEU Countries Extended the Transition Period for Medical Device Registration Until 2028

Елена Краснова Exclusive
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- On December 29, 2025, a Protocol was signed that amends the Agreement on Unified Principles and Rules for the Circulation of Medical Devices in the Eurasian Economic Union. This was reported by the Eurasian Economic Commission.

Key aspects of the new document:

- The transitional period for completing national registration of medical devices has been extended until 2028.

- The possibility of submitting applications for expertise and registration will be available until December 31, 2027, and will be carried out in accordance with both Union law and the national legislation of the member countries.

- Previously, the deadline for completing registration was set for December 31, 2025, after which, starting January 1, 2026, registration was to be conducted exclusively according to Union rules.

This extension of the transitional period will allow the EAEU states, including Kyrgyzstan, to optimize the registration system and smoothly adapt to the unified procedure based on Union rules.

The Protocol will come into temporary effect 10 days after signing and will remain in force after receiving the last written notification of the completion of domestic procedures by all Union members from the Eurasian Economic Commission.
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