The Council of the Eurasian Economic Commission has approved* amendments to the Agreement on Common Principles and Rules for the Circulation of Medical Devices within the Eurasian Economic Union dated 23 December 2014, which extend the validity of registration certificates issued according to the rules of the member states of the Eurasian Economic Union (EAEU) after 31 December 2021.
From 1 January 2022, medical devices will only be registered in accordance with the rules of the EAEU. According to the current rules, national registration certificates were to expire after 31 December 2021, which would make it impossible for these medical devices to remain on the market without re-registering them under the EAEU rules.
However, there is an expectation that this limitation will be lifted. According to the changes, registration certificates issued according to the national rules of EAEU member states will remain valid until they expire, and if national legislation does not provide for the validity period of certificates (as, for example, in Russia), they will remain valid indefinitely. Also, until 31 December 2026, it will be possible to replace registration certificates of a definite term with indefinite ones if the legislation of an EAEU state provides for it.
Within the specified time frame, medical devices accompanied by national registration certificates will be able to circulate in the territory of the EAEU member state where they were registered without any restrictions. At the same time, it will only be possible to make changes to the registration documentation of such medical devices until 31 December 2026.
Even though domestic approval of the protocol on amendments to the Single Market Agreement is required for the amendments to come into force, one can already state that national registration certificates are most likely to remain valid after 2021. This will give manufacturers of medical devices more time to carry out the necessary registration in accordance with the rules of the EAEU. It will also reduce the burden on regulatory bodies, which would have otherwise been forced to register thousands of medical device names almost simultaneously.
If you have any questions on this eAlert, do not hesitate to contact CMS Russia experts Vsevolod Tyupa, Alexey Shadrin or your regular contact at CMS Russia.
* In Russian
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