On 1 June, Resolution of the Cabinet of Ministers of Ukraine No. 377 entered into force. The Resolution abolishes the automatic extension of the validity period of marketing authorisations during martial law and provides for the extension of the validity period of marketing authorisations issued under the emergency registration and authenticity procedures for procurement by […]
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.
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