The European Business Association (Association) is pleased to inform about the solution of one of the problems faced by the companies supplying medical devices into the territory of Ukraine. Currently, obtaining a sanitary and epidemiological conclusion for medical devices was cancelled via amendments to the Resolution of the Cabinet of Ministers “Some issues of implementation of the state control for goods transported across the customs border of Ukraine” No. 1031 dated October 05, 2011. CMU Resolution No.44 dated 31 January 2018 states that a state sanitary and epidemiological expertise is not required for medical devices imported into the territory of Ukraine on the basis of a conformity declaration or a conformity certificate in accordance with the current legislation in the field of medical devices’ technical regulations (CMU Resolutions No.753, No.754, No.755 dated 2 October 2013).
The Association’s Health Care Committee first paid attention of governmental authorities to the necessity of having no sanitary and epidemiological control for medical devices in February, 2017. Regulatory acts effective at that time, anticipated no sanitary and epidemiological control for medical devices registered in Ukraine. However, following the transition of Ukraine’s system to the conformity assessment based on the EU legislation, medical devices’ supply into Ukrainian market started on the basis of a conformity declaration or a conformity certificate. As a result, an ambiguous situation emerged at the customs clearance of these products, which led to delays with medical devices’ supply to Ukrainian patients.
The Association is grateful to Ministry of Health of Ukraine, Ministry of Economic Development and Trade of Ukraine, Ministry of Finance of Ukraine, the State Fiscal Service of Ukraine, the State Service of Ukraine for Food Safety and Consumer Protection for involvement in the process of removing the barrier and expects that further amendments in the legislation of Ukraine will be made in a timely way.