In the healthcare world, the primary task of medical device registration remains the confirmation of their safety and efficacy. Modern standards demand a thorough evaluation of products before their placement on the market, emphasizing the significance of clinical trials (CTs). 

Until 31 January 2025, Russia retains the possibility of medical device registration according to national legislation, which allows for the conduct of CTs in accordance with the Order of the Ministry of Health of Russia No. 885n "On Approval of the Procedure for Conducting the Conformity Assessment of Medical Devices in the Form of Technical Trials, Toxicological Studies, and Clinical Trials for the Purpose of State Registration of Medical Devices". This procedure, known as clinical evaluation, often involves the analysis of clinical data without human participation. 

However, as the deadline for submission of documents under the national legislation approaches, manufacturers are increasingly paying attention to new rules approved by the Eurasian Economic Commission Council. These requirements mandate the conduct of multicenter studies for Class IIb, III, and implantable medical devices. To conduct such clinical research, it is necessary to obtain permission from the competent authority of the member state where these trials (studies) are planned to be conducted. 

Furthermore, for all classes of medical devices, except for Class I in vitro diagnostic devices, the registration dossier includes a report on the clinical evidence of the medical device's efficacy and safety, or its copy. 

This leads to a complication and prolongation of the medical device registration process due to the novelty of the procedure, a limited number of accredited medical institutions, and the complexity of the process. 

Inpharmatis provides medical device registration services in the EAEU countries (Russia, Belarus, Kazakhstan, Armenia and Kyrgyzstan), which include solutions for the successful completion of the medical device registration both according to national procedures in the CIS countries and according to EAEU Rules. Our comprehensive approach includes strategic planning, GAP analysis of documentation and its preparation, as well as submission and procedure management. 

Receive a personal offer for medical device registration or request additional information about the service via info@inpharmatis.com.

Article author
Stepan Kuropatkin,
Regulatory Affairs Specialist
Inpharmatis