An extension of the transitional period for the registration of medical devices has been announced until the end of 2027
On 17 December, the President of the Republic of Belarus signed Decree No. 441, approving two draft protocols to amend the Agreement on the Uniform Principles and Rules for the Circulation of Medical Devices within the EAEU dated 23 December 2014.
These documents will form the basis for further negotiations among the Member States of the Union.
The draft amendments:
- adjust the list of medical devices that are not subject to registration within the EAEU;
- provide for an extension, until 31 December 2027, of the transitional period during which registration is possible either under national legislation or under the EAEU rules.
This decision is aimed at ensuring the stability of the circulation (turnover) of medical devices and reducing the risk of shortages in the Union’s internal market.
We will continue to monitor developments and the final wording of the legislative amendments.
Authors: Aliaksandr Antonau, Sergey Suschenya, Denis Valukevich, Iryna Navitskaya.
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