Ukrainian Scientific Institute of Certification

Notified body representatives took part in the 5th anniversary ukrainian forum of medical device market operators


On 7 April 2016, the Rus Hotel, Kyiv, became the venue for the 5th anniversary Ukrainian forum of medical device market operators


The forum highlighted the economic situation and international experience with regard to the medical device market functioning and its specific directions. An interactive focus session with regulators representatives also took place. The attendees had an opportunity to put their questions to the representatives from the MOH, lead specialists from the Technical Regulation Department of the Ministry of Economic Development and Trade, and to the Chief State Inspector of Non-tariff Regulation from the Customs Department of the State Fiscal Service. One of the topics of immediate interest was the regulatory environment of the medical device market.

Among the invitees were also specialists from the conformity assessment body Uni-CERT.


Myroslava Boychuk, an auditor for the Ukrainian Scientific Institute of Certification (Uni-CERT), gave a presentation on the procedure for conformity assessment involving on-site audit. She answered the questions from representatives of the companies, described the key intricacies of the procedure, scope of documentation to be provided at the first and second stages of the audit, explained in which language the documents should be submitted to the authorities and in which language the audit should be conducted, pointing out that the volume of translation and the need for a translator/interpreter would depend on whether the authority employed auditors whose English was good enough to read the technical documentation and communicate during the audit. The speaker confirmed that the Uni-CERT auditors spoke English, which would let the market operators to optimize the costs of the procedure, as the volume of translation would decrease and there would no need to involve an interpreter.