Procedure for the Market Placement of Medical Products Procured by International Organization Simplified

On 30th December 2015, Resolution № 1163 "On Amendments to Some Resolutions of the Cabinet of Ministers of Ukraine” (hereinafter - Regulation), was adopted by the Cabinet of Ministers with which medical products procured through international organizations have easier access to Ukraine’smarket.

Therefore, the Regulation provides amendments to the technical regulations № 753, 754, 755 on medical products which were approved by the CMU from 02.10.2013., particularly for in vitro diagnostics and active medical implant devices.

Pursuant to the amendments, it will be permitted to enter the above mentioned medical products that are not bearing the national mark of conformity into circulation , subject to recognition of conformity from the designated conformity assessment body carried out by foreign accredited conformity assessment bodies , in accordance with the requirements of part three of Article 45 of the Law of Ukraine "On the Technical Regulations and Conformity Assessment", which in turn will take effect from 02.10.2016 year.

In particular, the above Article provides that national accreditation bodies are entitled to recognize the results of conformity assessment carried out by foreign authorities based on agreements with them , provided that :

• National accreditation bodies, both in Ukraine and in another state, are members of international or regional organizations of accreditation and / or an agreement on mutual recognition of such organization on relevant activities of conformity assessment.
• The designated authority, on the basis of a document of compliance issued by a foreign authority, shall apply the conformity assessment procedure or part of it and issue the relevant document under this procedure under its responsibility.

This Regulation shall enter into force six months after the date of publication and will be valid until 31st March 2019.

It is to be noted that these legislative changes are due to the implementation of public procurement procedures of medical devices involving specialized international organizations that provide states and other entities with related services.