On 18 April 2017, the Procedure for Maintaining the Register of Persons Responsible for Introducing Medical Devices, Active Implantable Medical Devices and Medical Devices for In Vitro Diagnostics into Circulation, approved by MOH Order No. 122 dated 10 February 2017 (the "Procedure"), became effective.
The Procedure was adopted to implement the requirements of the technical regulation on medical devices approved by Regulation of CMU No. 753 dated 2 October 2013, the technical regulation on medical devices for in vitro diagnostics approved by Regulation of CMU No. 754 dated 2 October 2013 and the technical regulation on active implantable medical devices approved by Regulation of CMU No. 755 dated 2 October 2013 (the "Technical Regulations").
The Procedure established that the manufacturers of medical devices or their authorized representatives (for non-resident manufacturers) are responsible for introducing medical devices, active implantable medical devices and medical devices for in vitro diagnostics into circulation. These persons are obliged to submit the notification in the form established by the Procedure to the State Agency of Ukraine on Pharmaceuticals and Control of Narcotics. The notification must contain information on the submitter’s official address, a list and description of the relevant medical devices, and a number of other details for certain in vitro medical devices. This obligation is only imposed in respect of class I medical devices, custom-made medical devices, medical devices for in vitro diagnostics and custom-made active implantable medical devices.
The manufacturers and their authorized representatives who had previously provided the relevant information to the State Agency of Ukraine on Pharmaceuticals and Control of Narcotics based on the requirements of the Technical Regulations are not released from the obligation to submit the new notification in accordance with the Procedure.