On 14 November 2016 the European Business Association received the confirmation from the State Service of Ukraine on Medicines and Drugs Control (SMDS) that the Draft Order on the Register of Physical Entities Responsible for Medical Device Circulation had been sent out to MOH for approval.
Natalia Serhienko, EBA Health Care Committee Executive Director expects that the regulation required for the medical device market will be in place as soon as possible:
“Now we have an official confirmation that the issue has finally been moved forward. Firstly, the primary version of the Draft Order on the Register of Physical Entities Responsible for Medical Device Circulation was developed and worked through by the SMDS together with the experts of the Association. Secondly, the Draft Order has already been sent to MOH for approval. Thus, we hope that this sub-legislative act will be web-placed soon for public discussion and adopted then.
It is a common knowledge for the medical devices market operators that the “transition period” during which these products are allowed to be imported and circulated based on their registration certificates only will last until 1 July 2017.
Starting from this date, the products will be imported and circulated only based on their declarations/certificates of conformity with the Technical Regulations on Medical Devices. Thus, in order to make the market surveillance work efficiently there should be in place the Register of Physical Entities Responsible for Medical Device Circulation which should be also regularly updated.”