Amendments have been made to the Action Plan of the Ministry of Health of Ukraine for the preparation of draft regulatory acts for 2021, approved by the order of the Ministry of Health of Ukraine dated December 15, 2021, № 2885. This is provided by the order of 21.04.2021 № 780.
The amendments stipulate, in particular, that by December 2021 the Ministry of Health should develop a draft order “On approval of the Procedure for conformity assessment of medical devices, including active implantable medical devices made using animal tissues.”
Legal basis – Article 8 of the Law of Ukraine “On Technical Regulations and Conformity Assessment”, Annex 3 to the Technical Regulations on Medical Devices, approved by the Resolution of the Cabinet of Ministers of Ukraine of October 2, 2013, № 753.
Executor – Directorate of Pharmaceutical Supply.