إجراء مقترح من كازاخستان: سلع من 3 فصول في النظام المنسق

The draft amendments to the Requirements for the implementation, maintenance and evaluation of the quality management system of medical devices, depending on the potential risk of their use, apply to medical devices put into circulation in the territory of the Eurasian Economic Union and provide for the following: the possibility, in certain situations, of confirming the compliance of the production conditions of the sterilization site with the established requirements without the inspection organization visiting the sterilization site, which will avoid repeating individual procedures when evaluating the quality management system in order to rationalize the resources of manufacturers of medical devices and inspecting organizations