On June 26, Chamber Working Group on Healthcare Hardware and Medical Devices Manufacturers and Chamber Working Group on Consumer Goods (Personal & Household Care) held a meeting with Iuriy Brovchenko, Deputy Minister of Economic Development and Trade of Ukraine and representatives of the respective Ministry regarding simplification of doing business in Ukraine, in particular:
According to CMU Resolution #1057 “On Determining the Areas in which Central Authorities Fulfill the Functions of Technical Regulation”, the functions of technical regulation on quality control and implementation of medicinal products (including medical devices, medicinal devices for in vitro diagnostics, and active medical devices for implantation) are fulfilled by the Ministry of Health of Ukraine.
The instructions for use and label of the medicinal product have to comply with the requirements of the Law "On Principles of the State Language Policy", so the issue is under the jurisdiction of the Ministry of Culture of Ukraine.
From its side, the Ministry of Economic Development and Trade of Ukraine is ready to participate in the trilateral discussion of amendments to the relevant regulatory acts.
A package of documents for ratification of Agreement on Conformity Assessment and Acceptance of Industrial Products is currently under consideration by the EU side. Discussion of the possibility of ACAA ratification within the framework of the first priorities is planned for autumn. Medicinal products and medicinal products for in vitro diagnosis are defined as the third priority.
Conformity assessment bodies should conduct an audit of the manufacturer directly. Replacing such an audit with the paper report is possible only if the conformity assessment body has a signed agreement with the relevant authority in the country of manufacturer location on the recognition of the audit results.