UA Ukraine
  • 11 - Medizintechnik

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.