Changes in the medical device regulation in Ukraine


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 Ukrainian market with confirmed safety and efficiency, on August 9, 2022, the Ministry of Health withdrew the letter dated February 25, 2022 No. 24-04/5396/2-22 allowing the placing of the medical devices on the market of Ukraine without meeting the requirements of the Technical Regulations and allowing 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”.

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

Letter of the Ministry of Health of Ukraine No. 24-04/18007/2-22 dated 08/09/2022 with translation

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