The purpose of the presentation: to introduce the principles and rules of treatment of medical products under the treaty of Belarus, Kazakhstan and Russian Federation, the appropriate perimeter of the agreement - the territory of the Eurasian Economic Union.
The scope clarified and related to medical devices under this agreement. Specified the harmonization of the Eurasian Union policies with IMDRF and GMDN.
Presented the order of registration of the medical devices, the registration documents and responsible representative for the release of the product into circulation in the territory of the Union. Specified which medical devices are not subject to registration.
Presentation sets out requirements for the production and labeling of medical products, as product safety and quality control and monitoring rules. The information given on the timing of the introduction of the provision and the transitional period.
Leonid Dvorkin, PhD. Russian Federation, SARL AFNOR Rus, Managing Director