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.
Relevant documents:
The Law of Ukraine “On technical regulations and conformity assessment”,
Resolution of the Cabinet of Ministers of Ukraine N 753 of 02 October 2013 “On approval of the Technical Regulation on medical devices”,
Resolution of the Cabinet of Ministers of Ukraine N 754 of 02 October 2013 “On approval of the Technical Regulation on in vitro diagnostic medical devices”,
Resolution of the Cabinet of Ministers of Ukraine N 755 of 02 October 2013 “On approval of the Technical Regulation on active implantable medical devices”.
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