On December 19, 2011 the Ministry of Economic Development and Trade of Ukraine and the Ministry of Health of Ukraine (further referred to as MOH of Ukraine) have endorsed the Joint Orders on Amendments to the Action Plans on the implementation of three technical regulations for medical devices in Ukraine. The Joint Orders had been already officially published on the MOH’s of Ukraine web resource.
Background: As far back as 2008 three Action Plans on mandatory implementation of terms and conditions of Technical Regulations for Medical Devices starting from 2012 there were endorsed. However, neither of the Action Plans contained procedures for the applicants (companies producing medical devices for their market circulation in Ukraine) to be able to physically fulfil the requirements set. Thus, the mandatory implementation of three Technical Regulations for Medical Devices in Ukraine starting from 2012 was a real threat for the import of these products into the territory of Ukraine.
EBA HCC Medical Devices Subcommittee addressed a number of letters on the problem to the MOH of Ukraine, the Ministry of Economy and Trade of Ukraine and the State Service for Medical Drugs of Ukraine, the latter being the Executive Body monitoring the terms and conditions of Technical Regulations.
On November 7, 2011 EBA HCC Board had a meeting with the Minister of Health of Ukraine Oleksandr Anishchenko and MOH’s higher officials and discussed the threat of actual stoppage of importing medical devices into the territory of Ukraine starting from January 1, 2012 should the Technical Regulations be a must in 2012.
As a result of the meeting, Mr Anishchenko made a commitment to postpone the Technical Regulations’ mandatory implementation for one calendar year, i.e. until 2013 due to unavailability of the necessary procedures in place.
We are happy to share this success with our members who have been waiting for the successful resolution of the problem with medical devices in Ukraine.