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
On May 19, a webinar was held on the topic: “Relevance of medical device conformity assessment through EC-certificates recognition during martial law”, the speakers of which were Viktoriia Shevchenko, Head of the Conformity Assessment Department of UNI-CERT LLC and Yana Sydiakina, Leading Specialist of the Assessment Division of UNI-CERT LLC. The seminar showed the great […]
Read moreAfter the events of 2014, Ukraine took the path of development, oriented towards the European Union. On September 1st, 2017, the Association Agreement between Ukraine and the EU entered into force. Ukraine assumed the responsibility to follow the path of harmonization with EU legislation and, as a result, some changes took place in the regulatory […]
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