On August 26, the 11th anniversary Ukrainian forum of medical device market operators took place, which provided manufacturers, suppliers, distributors, importers of medical devices with a platform for communication and exchange of valuable business experience during martial law.
Ukrainian Scientific Institute of Certification was traditionally a partner of this event. In addition, Victoria Shevchenko, Head of conformity assessment department, and Nikolay Matlaev, Lead specialist of conformity assessment division, made a presentation on the topic of Specific features of the medical device conformity assessment in wartime with and without conformity assessment bodies involvement, which highlighted issues related to:
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 martial law and a simplified procedure for placing medical devices on the Ukrainian market.
Text is available only in Ukrainian
Read morePROGRAM The importance of quality control of medical products for business Classification of medical products SI units Marking. Meaning of symbols. New symbols of 2022. Instructions for medical products Accompanying documents. Certificates of conformity. Declaration of conformity. Methods of checking the validity of certificates
Read moreWe are pleased to inform you that the notified body SGS Belgium NV (ID 1639) has signed an arrangement for the recognition of conformity assessment results with the UNI-CERT LLC. Due to this collaboration, our clients can significantly reduce their time and financial expenses for certification of their products in Ukraine. We have already accumulated sufficient […]
Read moreOr find the answer here
*All fields are required