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
By the Orders of the Ministry of Economic Development, Trade and Agriculture of Ukraine, the Ukrainian Scientific Institute of Certification was appointed as a conformity assessment body to perform, as a third party, certain conformity assessment tasks defined in the relevant technical regulation, in accordance with the new requirements of the Law of Ukraine “On […]Read more
PharmaTechExpo Journal | SPECIAL ISSUE 2021 The text of the article is available only in UkrainianRead more
Dear colleagues and partners! We are pleased to announce that UNI-CERT LLC has signed an agreement with the Turkish laboratory Ekoteks Laboratuvar ve Gözetim Hizmetleri. Ekoteks Laboratory is accredited according to the standart of ISO/IEC 17025 with the number of AB-0583-T by TURKAK (Turkish Accreditation Agency), an independent certification body which is a member of […]Read more