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.

Additional Information:

In August 2022, the Eurasian Commission proposed an extension to the transition period to switch from the national regulatory frameworks to the Eurasian Union regulation enforcement. The implementation of the EAEU unified procedure is extended to January 2026. Up today, Belarus has officially signed the protocol; therefore, they are accepting the submission under the national procedure until December 31st, 2025.

Other Europe (non-EU) Countries:
Bosnia & Herzegovina, Iceland, Liechtenstein, Macedonia, Moldova, Norway, Serbia, Switzerland, Turkey, Ukraine

Last updated on May 03, 2023.