Medical devices, in vitro diagnostic medical devices, active implantable medical devices
Draft Law of Ukraine "On Medical Devices" (9 page(s), in Ukrainian)
the draft Law aims at:
· elimination of ambiguous interpretation of the norms regarding classification of medical devices;
· reduction of the circulation of counterfeit medical devices;
· elimination of double proof of safety of medical devices (deregulation);
· regulation of advertising of medical devices;
· creation of legal grounds for the development of legal acts concerning clinical investigations and performance evaluation;
· determination of the legal grounds for taking market surveillance measures for all medical devices, regardless of the method of placing on the market;
· simplification of the conformity assessment procedure through the use of remote audits.