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 Centre for Examination and Testing in Health Service (NCE), a department of the Ministry of Health (MOH).

CLASSIFICATION SYSTEM: Medical devices are classified according to risk-based classification rules.

Medical Devices: Classes I, IIa, IIb and III.

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 is decided by local authorities during the document review process.

Class I: The registration process ranges from three to twelve months of working days. The duration of the process depends on the required clinical expertise, and is decided by local authorities during the document review process.

Class II: The registration process ranges from three to twelve months of working days. The duration of the process depends on the required clinical expertise, and is decided by local authorities during the document review process.

Class III: The registration process ranges from three to twelve months of working days. The duration of the process depends on the required clinical expertise, and is decided by local authorities during the document review process.

IVD Devices: The registration process ranges from three to twelve months of working days. The duration of the process depends on the required clinical expertise, and is decided by local authorities during the document review process.

SPECIAL REQUIREMENTS:

Audits: An audit is required.

Technical Local Tests: Clinical trials and electrical safety tests are required.

Clinical Evaluation/studies: Clinical trials in Belarus may be required.

LOCAL FEES:

Application review fees: The price calculation is based on the class, documents reviewed, local tests etc.

Manufacturer registration: A manufacturer registration fee is not applicable in Belarus.

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

LICENSE TRANSFER: License transfers are possible, paperwork is required.

AUTHORIZED REPRESENTATIVE/LICENSE HOLDER: An authorized representative is 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 April 1, 2019.

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