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.
Timeframe and fees
1-4 months (16 months in case of ongoing clinical investigation).
Labelling and documentation language
Documentation and labelling must be submitted in Russian.
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.