Meeting of the professional community of the medical device industry with the Minister of Health – Zoryana Skaletskaya

Written by admin October 16, 2019 0 comment

Director of the Archimed – Nikolay Romanok moderated the first meeting of the professional community of the medical device industry with the Minister of Health – Zoryana Skaletska.
During the meeting was discussed different level of questions: from general political to completely practical, which industry representatives face in their daily business activities.
Such as:
  • The place of medical devices in the transformation of the healthcare system of Ukraine;
  • Changes in the regulation of the European market for medical devices: consequences for Ukraine;
  • The regulatory impact of the Law of Ukraine “On ensuring the functioning of the Ukrainian language as the state language” on the medical device market;
  • State regulation of prices for medical devices: interim results of monitoring the abolition of the trade margin for medical devices purchased from state budget funds;
  • Compliance of conformity assessment bodies taking into account the requirements of the updated Law of Ukraine “On technical regulations and conformity assessment”;
  • Implementation of the national classifier of medical devices (GMDN) in the Prozorro public procurement system.
Participants of the meeting:
  • State Service for Drugs and Drug Control;
  • Department of Technical Regulation of the Ministry of Economic Development, Trade and Agriculture;
  • Pharmaceutical Directorate of the Ministry of Health of Ukraine;
  • The Ministry of Health’s expert group on medical products and cosmetics.
Within the framework of the event, Business Development Director of Archimed Evgenia Andrushenko, presented the main changes in the regulation of the medical device market in the European Union, focusing on key aspects that affect to importers and distributors of medical devices in third countries, including Ukraine.