Panel Discussion “Medical Devices Regulation in Ukraine"



  • Medical devices' place in transformation of healthcare system in Ukraine
  • Changes in medical devices regulation in the EU: implications for Ukraine
  • Technical regulations on medical devices – current changes and harmonization with EU Directives 2017/745 for medical devices and 2017/746 for in vitro medical devices
  • Law of Ukraine "On Ensuring the Functioning of Ukrainian as a State Language": major changes for the medical devices market
  • Medical devices price regulation: intermediate results of price monitoring
  • Conformity assessment bodies' functions due to updated Law of Ukraine "On Technical Regulations and Conformity Assessment"
  • Implementation of the National Classifier of Medical Devices (GMDN - Global Medical Device Nomenclature) into the public procurement system


Representatives of the following state authorities were invited to join the discussion:

  • Ministry of Health
  • Ministry of Economic Development, Trade and Agriculture
  • State Service of Medicine and Drug Control
  • Verkhovna Rada Committee on National Health, Medical Assistance and Health Insurance
  • Verkhovna Rada Committee on Economic Development


Moderator: Mykola Romaniok, Head of the Chamber Working Group on Healthcare Hardware and Medical Devices Manufacturers, CEO, Archimed.