Possibility to register medical products according to national rules extended

The Eurasian Economic Union States signed the Protocol on Amending the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Accessories and Medical Equipment) within the EAEU.

The document stipulates that until December 31, 2025 there is a possibility to file an application for examining or registering a medical product according to the procedure stipulated by the Union's law or legislation of an EAEU State. Earlier such possibility was offered until December 31, 2022 and it was supposed that starting from January 1, 2023 medical products would be registered only in accordance with the Union's law. 

Extension of the deadline set by the Protocol will allow Member States to improve the system required for transitioning to a unified procedure for medical product registration including, among other things, clinical centers and testing laboratories. A relevant plan was approved by the Eurasian Economic Commission's Council in December 2022. As was noted by Viktor Nazarenko, EEC Minister in charge of Technical Regulation, implementation of the planned activities will ensure unconditional transition to medical product registration according to the EAEU rules from January 1, 2026. 

The Protocol is provisionally applied from the date of its signing – February 13, 2023 – and will come into force from the date when the Commission receives the last written notice on the Union Member States having performed internal legal procedures required for it to come into force.