Inclusion in the medical devices registry

The process during which a manufacturer or their authorized representative submits a completed Notification to the State Service of Ukraine on Medicines and Drugs Control (State Drug Control Service) to be included in the Register of Persons Responsible for Placing Medical Devices, Active Implantable Medical Devices, and In Vitro Diagnostic Medical Devices on the Market. The Notification is submitted through the Responsible Person’s Cabinet.

Inclusion in the Register of Persons Responsible for Placing Medical Devices on the Market is a registration procedure for physical and legal entities involved in the placement of Class I medical devices, as well as manufacturers of custom-made devices and certain in vitro diagnostic devices.

The Register is maintained by the State Service of Ukraine on Medicines and Drugs Control and contains information about medical device manufacturers authorized to place their products on the market within the country.

To be included in the Register, the manufacturer must submit a request to the State Drug Control Service along with the required documentation—Notification, Declaration of Conformity, and other documents proving compliance with legal requirements. After completing all necessary procedures and addressing any issues, the manufacturer is granted the right to place their medical devices on the market and is added to the Register.

The request for inclusion in the Register can be submitted by the manufacturer.