[Blog] Transforming healthcare: The evolution of medical devices rules in CIS countries (part 2)
In our second article about the medical devices rules in CIS region we will focus on the countries – Belarus, Ukraine and Russia.
In Belarus, the Department of Medical Equipment under the Center for Examinations and Tests in Health Service (NCE) operates under the Ministry of Health (MoH).
The recent developments in regulatory deadlines indicate that Belarus has signed the protocol to transition from national to Eurasian Union regulation enforcement by January 2026. Until then, they are accepting submissions under the national procedure until December 31, 2025. It’s essential for foreign manufacturers to appoint an Authorized Representative responsible for registration.
The State Service of Ukraine on Medicines and Drugs Control is the central executive authority whose activities are directed and coordinated by the Cabinet of Ministers of Ukraine through the Minister of Health of Ukraine.
In August 2022, the Eurasian Commission proposed an extension to the transition period to switch from the national regulatory frameworks to the Eurasian Union regulation enforcement. The implementation of the EAEU unified procedure is extended to January 2026.
Authorized representation is required, and medical devices are classified into risk-based categories of Classes I, IIa, IIb, and III.
Federal Service for Surveillance in Healthcare (Roszdravnadzor) is the federal service of the Russian Federation that exercises control and supervision functions in the field of healthcare.
In accordance with Decree No.139 of February 2022, commencing from September 1, 2023, the mandatory registration in the labeling system is enforced for specific categories of medical devices that require identification labeling. This requirement applies to all participants involved in the distribution and circulation of these medical devices.
As per Decree No. 894 issued in May 2023, the following mandatory labeling requirements will take effect:
- Starting from October 1, 2023, labeling will be mandatory for disinfectants, air purifiers, orthopedic footwear, and insert corrective elements for orthopedic footwear.
- Effective from March 1, 2024, other specific types of medical devices subject to compulsory labeling will also be required to comply with this regulation.
The remaining member states of the CIS region are currently engaged in deliberations and the publication of forthcoming regulations.
In addition, they are actively working on the implementation of more stringent standards and requirements for medical devices. These efforts are driven by the ultimate goal of improving healthcare provisions for their respective citizens.
All these regulatory changes may involve some adjustments, but they ultimately contribute to the growth of the medical device industry in the CIS region, benefiting both patients and the healthcare sector as a whole.