Prolongation of the transition period to the common rules of medical devices registration is on the ECE agenda
The agreement on the unified principles and rules of trade of medical devices in the EAEU countries is subjected to new changes. The ECE Council decided to prolong the transition period to unified registration rules till 2025. That means that until this time, national system of state registration of medical devices is used.
The protocol project has already been published for the people to discuss it. The project provides the possibility of unlimited prolongation of national registration in each country in case of epidemic state, military state or another significant social-economical factor. Within 90 days, the EAEU member countries should inform the Council on following the internal state procedures that are required for acceptance of this document.
This mechanism is developed also for the cases of deficiency of medical devices s a result of the abovementioned factors. Within the given period, the countries establish the state registration procedures by themselves and the measures will be taken during the period of crisis and elimination of its consequences.