Medical Device Registration and Approval in Belarus

General country-specific regulatory information is provided on this page for medical device registration and approval in Belarus. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Belarus, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in Belarus

REGULATORY AUTHORITY: Medical devices are regulated by the Ministry of Health (MOH).

CLASSIFICATION SYSTEM: Medical devices are classified according to EU risk-based model into Classes I, IIa, IIb, III, and IV.

TIMEFRAME: 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.

LICENSE VALIDITY: Licenses issued in Belarus are valid for five years.

AUTHORIZED REPRESENTATIVE: An authorized representative is not required.

ADDITIONAL INFORMATION: 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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