Lidia Sangarovskaya Spoke About the Mandatory Measures for Manufacturers and Distributors to Ensure the Safety of Medical Products Introduced Into Circulation in Ukraine
On February 22nd, 2018 Kyiv hosted IIІ International Forum “Circulation of Medical Products in Ukraine – 2018” organized by UkrMedSert company. The State Service of Ukraine for Drugs and Drug Control, GMDN Agency (Global Medical Device Nomenclature, United Kingdom), the Conformity Assessment Authorities authorized to assess the compliance of medical products with the requirements of technical regulations, as well as representatives of the medical products market participated in the event.
The Forum highlighted the current condition of the market of medical products in Ukraine “in figures”, the main problems and ways of their solution in terms of assessing the conformity of medical products, the problem of the competence of the personnel of conformity assessment bodies, as well as the personnel of manufacturers of medical products and their authorized representatives in Ukraine, the practical aspects of the transition and effective application of ISO 13485: 2016.
Legal Alliance Company was represented at the event by senior associate Lidia Sangarovskaya, who told the audience about the specifics of the implementation of measures to ensure the safety of medical products by manufacturers and distributors and notification of the State Service of Ukraine on Medicines and Drugs Control about unsafe products.
“The manufacturer (distributor) does not file a notice of unsafe products to the State Service of Ukraine on Medicines and Drugs Control if within 2 working days from the date it becomes aware or should become aware that the relevant products carry risks to consumers (users), it has taken all corrective measures in respect of all relevant units of such products and withdrawn them from circulation,” Lidia emphasized.