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.
Last updated on November 5th, 2021.
Medical Device Regulations and Classification in Belarus
Regulatory Authority: Department of Medical Equipment of Center for Examinations and Tests in Health Service (NCE) that working under Ministry of Health (MoH).
Classification System: Medical Device and IVD: I/IIa/IIb/III
Timeframe: According to our experience the whole registration process will takes around 3 months for medical device and 5 months for medical equipment.
Special Requirements: As part of technical examination procedure, the following process are required:
Factory inspection – except for class 1 (non-sterile) with less than 20 SKUs and devices that have been registered in both EU and US.
Local testing – Depending on the type of medical devices and applicable standards, some devices are subject to the technical testing.
Local clinical trial – clinical expert will decide whether the local clinical trial is necessary or not. However, in most cases, devices that are manufactured in the EU or US, except for implantable device such as stent, are exempt from this requirement.
Local Fees (New Application):
Initial Examination – USD 394.
Expert Examination & National State Registration (medical equipment) – USD 2204 for the first group and USD 440 for the next group.
Expert Examination & National State Registration (medical devices) – USD 1536 for the first group and USD 307 for the next group.
Local Fees (Manufacturer): No local fees are required.
License Validity: 5 years for both medical devices and medical equipment.
License Transfer: License transfer is not applicable.
Authorized Representative: Foreign manufacturers intending to import medical devices in Belarus must appoint an Authorized Representative who is also responsible for the registration.
According to EEC Decision #142, the Belarus National State Registration will be allowed only until 31 December 2021 after which all new registration submissions must be made using the harmonized Eurasian procedure.
Devices that have been registered in both EU and US are eligible for accelerated registration process.
Last updated on April 22, 2021.
Other Europe (non-EU) Countries:
Bosnia & Herzegovina, Iceland, Liechtenstein, Macedonia, Moldova, Norway, Serbia, Switzerland, Turkey, Ukraine
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