Alert on changes in regulation of medical devices in Ukraine

We previously informed that the Ministry of Health of Ukraine by letter dated February 25, 2022 No. 24-04/5396/2-22 allowed the placing of the medical devices on the market of Ukraine without meeting the requirements of the Technical Regulations, and also allowed the labeling of such medical devices without meeting the requirements of the Law of Ukraine “On ensuring the functioning of the Ukrainian language as a state language”.

Please, note that on August 9, 2022, the Ministry of Health withdrew the mentioned letter in connection with the establishment of conformity assessment processes and the possibility of carrying out works that ensure the availability of the necessary products on the market of Ukraine with confirmed safety and efficiency.

Medical devices, active implantable medical devices and medical devices for in vitro diagnostics that have been put into circulation based on the Letter No. 24-04/5396/2-22 are allowed to be placed on the market before their expiration date.
   letter 25.02.2022 № 24-04/5396/2-22(3 pages)

  withdrawn letter(2 pages)


Stay informed - subscribe to our newsletter.

Baggovutivska str. 17-21, 6th floor, 04107, Kyiv, Ukraine
work days at 9-30 to 18-00 by Kyiv time (GMT +02:00)