Regulatory Authority
Republican Unitary Enterprise Centre for Examination and Testing in Health Service (NCE), department of the Ministry of Health (MOH).
Classification
I, IIa, IIb, and III.
The device may be classified differently from the EU classification depending on the intended use of the device.
Devices with Russia approval are more likely to be classified according to the determination of the Russian authorities.
Quality system
For all Medical Devices a Quality Management System (QMS) must be implemented in order to demonstrate their compliance with the Good Manufacturing Practice (GMP) requirements.
Further information on devices quality can be provided in order to decide whether clinical investigations are necessary or not.
All Medical Devices must be registered with the Belarus MOH.
Belarus only issues licenses for Medical Devices already bearing the CE Marking.
Foreign manufacturers intending to import Medical Devices in Belarus must appoint an Authorized Representative.
If the applicant is applying for a license for the first time, either an inspection is required at the manufacturing site or local clinical tests must be completed.
Applicant
Authorized Representative.
Timeframe and fees
1-4 months (16 months in case of ongoing clinical investigation).
Validity
5 years
Labelling and documentation language
Documentation and labelling must be submitted in Russian.
Useful information
If the manufacturer does not hold the license or he is not the direct applicant, he cannot transfer or modify the license.
As a member of the Eurasia Economic Community (EEC) and the Commonwealth of Independent States (CIS), the regulation system of Medical Devices and in Vitro Diagnostic Devices (IVD) is very similar to the Russian system.
