On May 14, the 10th anniversary Ukrainian forum of medical device market operators took place, which traditionally provides manufacturers, suppliers, distributors, importers of medical devices with a platform for communication and exchange of valuable business experience.
Ukrainian Scientific Institute of Certification was a partner of this event. In addition, Anna Telpiakova, First Deputy Director of UNI-CERT LLC, during the session “Technical regulation and conformity assessment of medical devices” made a report on the certification of medical devices during a pandemic, especially drawing the attention of the participants to the most important issues in such a situation, related to remote audits and the recognition of the results of conformity assessment carried out outside of Ukraine.
After the end of the session, a lively discussion took place with the participation of representatives of state, regulatory and supervisory authorities, in which possible practical solutions were discussed to overcome the difficulties of market participants associated with maintaining the validity of certificates during a pandemic and a simplified procedure for introducing medical devices to the Ukrainian market.
The program of the event is available only on Ukrainian
Read moreDear volunteers, friends, colleagues! The Ukrainian Scientific Institute of Certification has its own accredited testing laboratory, which provides laboratory testing for compliance with the requirements of 49 international and domestic standards for 146 test methods for medical devices and personal protective equipment. If you or your partners need to conduct laboratory tests of products supplied […]
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