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The Ministry of Health has approved an action plan for the preparation of draft regulatory acts for 2021

The Ministry of Health of Ukraine by order of 15.12.2020 № 2885 approved the Action Plan of the Ministry for the preparation of draft regulatory acts for 2021 (hereinafter – the Plan).

The full text of the Plan is available at the link.

In particular, during 2021 in the market of medical devices the Ministry of Health plans to develop:

  1. in March 2021, the order “On approval of the Procedure for placing on the market and operation of certain medical devices, medical devices for in vitro diagnostics and active implantable medical devices, which do not meet the requirements of technical regulations, but whose use is necessary in the interests of health” i ”in order to enable the introduction into circulation and operation of certain medical devices, medical devices for in vitro diagnostics and active implantable medical devices, for which the requirements of technical regulations are not met, but the use of which is necessary for the interests of health;
  2. in July 2021, a draft order “Some issues of the electronic inventory management system of medicines and medical devices” eStock “in order to create a timely centralized provision of patients in Ukraine with medicines and medical devices; establishing the process of monitoring drug residues in health care facilities;
  3. in December 2021, the draft resolution of the Cabinet of Ministers of Ukraine “On approval of the Technical Regulation on medical devices for in vitro diagnostics” to harmonize the legislation of Ukraine on technical regulation of medical devices for in vitro diagnostic with Regulation (EU) № 746/2017 of the European Parliament and the Council for Medical Devices, the removal of legal, administrative and technical barriers to trade, the implementation of European approaches to the placing on the market and operation of medical devices for in vitro diagnostics;
  4.  in December 2021, a draft resolution of the Cabinet of Ministers of Ukraine “On approval of the Technical Regulation on medical devices” for the purpose of Ukrainian legislation on technical regulation of medical devices with Regulation (EU) №745 / 2017 of the European Parliament and of the Council on medical devices. administrative and technical barriers to trade, implementation of European approaches to the introduction into circulation and operation of medical devices.

In total, the order provides a list of 44 draft regulations that the Ministry of Health plans to develop next year.

It should be noted that the Plan does not provide for the development of the draft Law of Ukraine “On Medical Devices”, as well as any draft on the resumption of the procedure of state regulation of prices for medical devices.

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