Registration of medical devices in Belarus-bg

Registration of medical devices in Belarus

Healthcare expenses in Belarus are gradually rising: compared to the previous year, in 2022 they increased by 10% in terms of budget allocations. 

Belarus is an active member of the EAEU and due to the agreement about medical device registration among the countries, they should complete a transaction from the national system to the Union’s regulation by the end of 2025.  

According to the national registration system, there are authorized bodies responsible for different types of MD evaluation: 

The Center for Examinations and Tests in Health Service reviews documents in a registration dossier while accredited by the MoH laboratories and clinics conduct technical and clinical trials. They are submissive to the Ministry of Health - the body that issues the Registration Certificate at the very last stage of the process. 

This is what the enlarged national registration procedure looks like: 

Stage 1 takes about 15 calendar days: documents submission to the Center for Examination

Stage 2 takes about 150 calendar days: carry out a complex of preliminary technical trials 

Stage 3 takes about 15 calendar days: receive your Registration Certificate

What else is important to know about MD registration in Belarus:

Primary documentation review can be processed online

No inspection of a production site is required if a manufacturer is already registered in the country or has CE Mark and FDA, or if a medical device is 1 risk class non-sterile

Clinical trials are obligatory for any new MD or manufacturer and have to be carried out on people

Foreign manufacturers are released from technical trials

The national registration certificate has no expiry date

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