Meeting of the Working Group on Healthcare Hardware & Medical Devices Manufacturers


On September 5, the Chamber Working Group on Healthcare Hardware & Medical Device Manufacturers held its meeting focusing on discussion of the main priorities and the election of the Head for this newly created Working Group.

The participants agreed to:

1. Consider as a priority technical regulation of the market, rules of the marking and conformity assessment with regard to automatic recognition of conformity assessment certificates of EU and USA in Ukraine (FDA & CE under ACAA Agreement);

2. Promote information protection by conformity assessment bodies during examination processes;

3. Drive changes to CMU Resolution #410 which allows VAT rate manual regulation on medical devices and hardware products to be treated as medicinal products with a single, uniform tax rate;

4. Consider “grey” and parallel importing of hardware products and medical devices as the priority, and promote the idea of establishing a Working Group with stakeholders such as State Fiscal Service of Ukraine, National Border Service of Ukraine, and other involved services and organizations;

5. Find a solution together with stakeholders regarding price declaration processes, with consideration given to the unstable currency exchange rate in Ukraine;

6. Drive the creation of the Registry of Medical Devices;

7. Promote profiled law, the purpose of which should be to regulate the market hardware and medical device relations;

8. Promote the signing of the Agreement on Conformity Assessment and Acceptance of industrial products by the Government of Ukraine;

9. Consider as a priority the creation and promotion of the procedure for registration of medical devices containing medicinal products.

During the meeting, participants decided also to cooperate closely with the specialized Association of Market Operators of Medical Devices to plan a meeting with the Head of the State Fiscal Service of Ukraine to highlight main industry issues regarding “grey” import and VAT rate regulation. Members of the Working Group decided to plan a meeting with conformity assessment bodies to discuss a possible method of development for recognition of conformity assessment certificates of EU and USA in Ukraine, and guarantee information protection. Members agreed also on the necessity of elaboration of a specialized White Paper that could be presented to the stakeholders as an effective action plan to reform the sector.

By the unanimous decision of the participants of the Working Group, Mykola Romaniok, Cratia, was elected as a Head of the Chamber Working Group on Healthcare Hardware & Medical Device Manufacturers.