On November 22nd a seminar on putting on circulation and realization of medical devices in Ukraine, initiated by Legal Alliance Company, brought together representatives of the industry.
Tetiana Koba, counsel of acting Minister of Health on issues of reforming procurement of medicines and medical devices, reported on the action plan of the Ministry of Health on regulation of medical device market for 2019 and stages of GMDN introduction, namely – creation of a single platform of medical devices identification for international industry information exchange in the world. The anticipated result of GMDN introduction will become structuring of medical devices to monitor the market, control medical devices safety and avoid manipulations of healthcare facilities at procurement announcement. In particular, Ms Koba underlined that the main aim of all processes is safety of patients, and also invited representatives of medical devices market companies to active interaction with the Ministry of Health.
Due to participation of Iryna Gorlova, Director-General of SMD, participants of the seminar received analytical data on medical devices market for 2018 in retail segment and public procurement, as well as results of medical devices import monitoring.
Darya Bondarenko, event moderator and Executive Director of AMOMD, represented a survey of the Association´s activities in 2018 and dwelled on a number of projects of regulatory policy and industry norm-making on the medical device market which take place with active participation of AMOMD.
The seminar ended with a report of Nataliia Abramovych, associate at Legal Alliance Company, on legal regulation of medical devices circulation. Nataliia dwelled on the most spread mistakes at putting medical devices in circulation, in particular non-observance of marking with compliance sign and wrong number of compliance assessment authority; wrong indication of the authorised representative; non-compliance of medical device label with technical regulations and others. Assessment of compliance and marking of medical devices caused a heated debate among participants among the participants.
The event focused on the transformation of Ukraine's intellectual property sector on its path toward European integration.
Improving access to safe and affordable medicines for the Ukrainian population is one of the Government of Ukraine's top priorities. SAFEMed Activity (2017-2025) has supported this effort by appIying health system strengthening best practices.
The Ministry of Health website has posted a notice about the release of a revised draft order of the Ministry of Health ‘On Approval of Amendments to Certain Re
On 25 September, a webinar was held on the topic: ‘180 days of new drug price regulation. Results, prospects and practical advice.’ The event was organized by LA Law Firm in partnership with Proxima Research International.
