Ukraine launches updated electronic version of the Register of Medical Devices


In January 2023, the Ministry of Health of Ukraine (MoH) revised the Procedure for maintaining the register of persons responsible for placing medical devices, active implantable medical devices and IVDs on the market through Order #2311 dated 21 December 2022, (Procedure). This register collects information not only about responsible persons but about each medical device that is allowed to be marketed in Ukraine (Register of Medical Devices or RMD). The amendments came into effect on 25 January 2023 and already in January 2023 the State Service of Ukraine on Medicines and Drugs Control (SSMD) launched a new version of the electronic of RMD.

The RMD is already publicly available on the official website of the SSMD. The website has an English interface, but the database currently is only in Ukrainian.

The RMD is an important part of the eHealth ecosystem. Previously, RMD was only available as an Excel document, but the new digital solution is fast becoming a platform for data exchange and interaction between all market participants.
The new RMD contains the following information (in Ukrainian and English (if information in English has been provided by the applicant)):

  • manufacturer (name, legal address);
  • responsible person (name, legal address);
  • name of the medical device, its type, brand name, model, catalogue code;
  • description of the device;
  • declaration on conformity and, if available, certificate of conformity;
  • code and name of the device in accordance with the National Classifier NK 024:2019 Classifier of Medical Devices;
  • ISO code.

The search through the RMD includes possibility of filtering information according to the manufacturer, responsible person, code in accordance with the National Classifier NK 024:2019, name of the medical device, trade name, model, No. of the record in the RMD, and ISO code.

The Procedure has established a transition period whereby until 1 July 2023, it will still be possible to submit the notification on entering the information in RMD in paper format (along with electronic versions). Following the transition period, any notification can be submitted only through the electronic cabinet using a qualified electronic signature of the responsible person. The consideration period for such notifications is limited to 15 business days. 

For more information on opportunities in Ukraine's medical-device sector, contact your CMS client partner or local CMS experts: Borys Danevych, Anna Pogrebna.