Ukraine: MOH Executes Revised Procedures of Maintaining Register of Responsible Persons

The transitional period for notification submissions of registering medical device information in paper form alongside electronic submissions ends on 1 July 2023. After the date, all registration-related notifications must be submitted electronically via the Register of Medical Devices (RMD) using the electronic signature of the Responsible Person.

The Ministry of Health of Ukraine (MOH) has mandated the Order No. 2311 “On Amending the Procedure for Keeping the Register of Responsible Persons for Introduction of Medical Devices, Active Implantable Medical Devices, and Medical Devices for IVD into the Market” on 25 January 2023, with the target to enhance the efficiency and simplify the medical device registration into the circulation.

The RMD system contains the information of the registered Responsible Person and the medical devices registered in the market. As the RMD system is publicly accessed, the platform can facilitate digital data exchange with data searching equipped with information filtering. The filter search provided in the system is according to the manufacturer, responsible person, trade name, ISO code, or trade name.

Source: State Service of Ukraine on Medicines and Drug Control (SSMD)