The Ministry of Health of Ukraine approved guidelines that are developed on the basis of relevant documents of the European Commission (MEDDEV) for an unambiguous interpretation of technical regulations regarding medical devices, medical devices for in vitro diagnostics and active implantable medical devices.
The recommendations are not legally binding, but should be taken into account by manufacturers, authorized representatives, conformity assessment bodies and state market surveillance authorities, and other medical device market operators.
Download guidelines here
The Ukrainian Scientific Institute of Certification invites you to take part in the 12th Ukrainian Forum of Medical Devices Market Operators®. In this difficult period for our country, more than ever, it is necessary to be aware of the latest key changes in the functioning of the medical device market. Therefore, the Ukrainian Forum of […]
Read morePharmaTechExpo Journal №1-2, 2020. The text of the article is available only in Ukrainian
Read moreThe European Business Association invites you to a meeting dedicated to the current issues of updating technical regulations in the field of medical devices, which will be held on May 8 at 10:00. The new requirements will have a significant impact on manufacturers, importers, distributors, and authorized representatives of medical devices. Issues for discussion: Changes in […]
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