Registration of medical devices

The procedure was abolished on July 1, 2015, in Ukraine. In place of registration, a conformity assessment process was introduced. Depending on the risk class, medical devices are either entered into the Register of Responsible Persons for placing medical devices, active implantable medical devices, and in vitro diagnostic medical devices on the market, or assessed by a conformity assessment body according to the risk class.

Medical Device Registration – this is a process that involves obtaining a certificate of conformity from a conformity assessment body or entry into the Register of Responsible Persons at the State Drug Administration of Ukraine, depending on the risk class.

The registration of a medical device involves the submission of a set of documents by the manufacturer or their representative, typically including information about the device, its intended use, composition and technical specifications, safety and effectiveness studies, instructions for use, and other additional information in accordance with legal requirements and quality standards. Generally, registration requires passing a conformity assessment against established quality standards or being entered into the Register of the State Drug Administration.

Medical device registration is an important step for manufacturers and suppliers of medical devices, allowing them to conduct lawful activities within the country and gain access to the medical device market.