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Medical devices are regulated by the Ministry of Health (MOH).
Medical devices are classified according to EU risk-based model into Classes I, IIa, IIb, III, and IV.
The registration process ranges from three to twelve months of working days. The duration of the process depends on the required clinical expertise, and decided by local authorities during document reviewing process.
Licenses issued in Belarus are valid for five years.
An authorized representative is not required.
All documents submitted should be in Russian. An inspection of the manufacturing facilities by MOH authorities is usually required.
Last updated on January 29 2015.
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For more information on registration in Belarus, check out the following articles on our blog:
Country at a Glance: Belarus