The EEC Council approved a transitional period for the treatment of medical devices according to national rules until 2026
The Council of the Eurasian Economic Commission (EEC) approved amendments to the “Agreement on uniform principles and rules for the circulation of medical products.” The changes relate to the transitional period and will come into force after the project is signed by representatives of all member countries of the Union.
Amendments are supposed to be made to Art. 11 “Agreement on common principles and rules for the circulation of medical products within the Eurasian Economic Union” dated December 23, 2014.
In particular, medical devices, the dossier of which will be submitted for registration under national rules by December 31, 2021, will be able to receive documents under the old rules. Amendments to the registration certificate issued by the participating country will be possible until December 31, 2026, according to national rules.
Medical devices registered in accordance with national regulations can be released into circulation in the territory of the state of receipt of the dossier until the expiration of the national registration certificates. Medical devices with a limited period of validity will be eligible to re-register according to national rules until December 31, 2026.
The “Agreement on Unified Principles and Rules for the Circulation of Medical Devices” was adopted in December 2014. According to it, it is assumed that from January 1, 2022, the registration of medical products in the territory of the EAEU member countries will be carried out according to the unified rules of the Union. Amendments to the document establishing a transitional period were developed in September 2019. In March 2021, the draft amendments were approved by the EEC Board.
As follows from the EAEU Unified Register of Medical Devices, as of April 2021, five medical devices were registered under the new rules – two sets of reagents from NPO Diagnostic Systems LLC, a phototherapeutic neonatal irradiator produced by PO UOMZ (part of Rostec State Corporation), magnetic therapy apparatus “Almag +” of the Elatomsky instrument plant and Belarusian histological cassettes of the production association “Litoplast”.