The media office of the Council of the Eurasian Economic Commission that prolongation of registration of medical devices according to the national rules till the 31st of December, 2025, will allow to create smoothly the united EAEU market of medical devices. The corresponding correctives will come into legal force from the moment all the EAEU member countries accept the protocol with signature.
It has been planned to implement registration only according to the EAEU rules since the 1st of January, 2022. However, it is decided to postpone the deadline of the national registration. Due to clarifying of the requirements and preparation of the corresponding documents, the national registration in the Russian Federation had been interrupted since January till the middle of June of the present year and the medical devices in this period had been registered only according to the EAEU rules.
One of the reasons for prolongation of the national registration is the appeal of about 150 vendors and manufacturers of medical devices to the Government of the Russian Federation. Transition to the EAEU rules and implementation of sanctions put nine years of development of the national registration and the active procedure for entering of new devices into the market at risk.
The vendors asked to prolong the national registration till 2027, but the Ministry of Healthcare in July, 2022, tended to restrict the period to 2023. As we can see, the parties reached a compromise and the national registration is prolonged till the 31 of December, 2025.