A unified information system that will allow to launch the registration process for medical devices in accordance with EAEU requirements is not ready, said Dmitry Shchekin, the Deputy Head of the Division for Coordination in the Area of Circulation of Medicines and Medical Devices, Department of Technical Regulation and Accreditation of EEC.
“The registration of medical devices under the common rules is delayed mainly because the information system is not ready. According to the plans, it would have started operating this May. But it didn’t. Connecting five countries to a unified system is not an easy task,” said Dmitry Shchekin.
The system exists at the level of EEC, the main issue is to connect it to the systems of EAEU member states. Dmitry Shchekin noted that, in May, during a working meeting, the representatives of Kazakhstan and Russia declared that their countries needed another three months to complete the works.
“The states have different problems. Somewhere, it’s enough to just pass the cable, while, for example, in Kazakhstan, you need to make many changes to the software,” said Dmitry Shchekin.
EEC hopes that the system will start operating in the next two months. As a result, according to the experts, the launch of EAEU common market of medical devices is three months behind the schedule.