‘Premier Expo’ in conjunction with the Ukrainian Scientific Institute of Certification on June 14 at MIM Business School organized and conducted an educational event on topical issues of inspections by government market surveillance authorities of medical devices in aesthetic medicine and dentistry for managers of distributors and suppliers, regulatory managers of authorized representatives. For effective use of such a meeting, a discussion panel format was chosen, thanks to which participants received answers to all of their questions during the speakers’ speech.
In the first part of the event, Dmytro Sudak, a lawyer and legal officer in the field of pharmacy and medical devices, described the legal “field” in which the distributors of medical products are located. After him, Olena Nazarchuk, Head of the Department of Conformity Assessment of Medical devices of the Ukrainian Scientific Institute of Certification, spoke about the requirements of regulations regarding labeling and documentation on medical devices, as well as the next changes that are expected in the technical regulation on medical devices in Ukraine.
In the second part, employees of the State Service of Ukraine on Medicines and Drug Control, who are directly related to inspections of medical devices from distributors, spoke and shared their experience. Diana Surova, deputy head of the State Service in the Kyiv region, demonstrated the results of state market surveillance of medical devices in 2018 and its prospects for the 2019th. And Kateryna Lyukhanova, Head of the State Supervision (Control) Department of the Quality of Medical devices of the State Service in Kyiv, told about the rights and obligations of market supervisors and business entities during inspections.
A few years ago, such an event with the participation of employees of the State Service of Ukraine on Medicines and Drug Control would be simply unrealistic. But thanks to the positive changes that are occurring in this state body, today there is an opportunity to hear answers to your questions firsthand. After this event, our participants changed their attitude to the inspection process and they lost the stereotypes that were formed in previous periods of the State Service, and they left with confidence that the coming changes will only happen for the better!