Owing to the effective collaboration with the State Service of Ukraine on Medicines and Drug Control (hereinafter – SMDC) and Ministry of Health of Ukraine (hereinafter – MOH) as well as steady support from the EBA Health Care Committee, the ‘Register of Persons Authorized to Introduce the Medical Devices, Active Medical Devices and Medical Devices for In Vitro Diagnostics’ (hereinafter – the Register) was approved by the MOH Order №122 dated 10 February 2017 (hereinafter – Order №122).
Starting from 2015 the EBA repeatedly brought to the attention of health care state authorities the issue of unavailability of the elaborated Register and the necessity to adopt it due to the transition from the state registration system to the conformity assessment system for medical devices.
The Register will contain information about persons responsible for introduction, the listing and description of medical devices. The Register will be maintained by the SMDC, the authority responsible for the market surveillance of medical devices.
The EBA expresses its gratitude to MOH and the SMDC for the elaboration and adoption of this important bylaw. We hope that state authorities will appropriately stabilize the functioning of this new instrument and ensure its prompt filling-out and updating the information in order to eliminate any barriers in the medical devices circulation. The Register’s efficient functioning should facilitate the products’ circulation control.
The EBA looks forward to the publishing of the Register on the official sources.