Belarus, a member of the Eurasian Economic Union (EAEU) since 2015, along with Russia, Armenia, Kazakhstan, and Kyrgyzstan, has switched to a unified, supranational medical device registration system. After a transitional period during which national registration was also permitted, as of January 1, 2026, registration of Medical Devices will be possible exclusively through the EAEU system.

EAEU Registration Procedure

The procedure is standardised and involves several Member States:

1. Choice of Reference State
   The applicant selects an EAEU Member State (e.g. Belarus or Russia) that will guide the entire evaluation and approval process.
2. Involvement of other Member States
   It is mandatory to be involved in at least one other EAEU Member State. This ‘involved’ state will examine and approve (or reject) the conclusions and decisions made by the reference state.
3. Registration Dossier
   The complete documentation, in electronic format, is submitted via the EAEU platform operated by the Eurasian Economic Commission (EEC).
4. Technical evaluation and testing
   The Reference State carries out the technical evaluation of the dossier and manages any laboratory tests needed to verify the safety and performance of the device.
5. Manufacturing Site Inspection
   This inspection is mandatory for complex, innovative or Class IIa (sterile), IIb and III devices. It is conducted by the reference state according to Good Manufacturing Practice (GMP) standards.
6. EAEU Certificate of Registration
   Once the device is approved by both the reference state and all member states involved, the EAEU Certificate is issued. This certificate is valid in all EAEU countries that actively participated in the procedure.
   For other EAEU countries not initially involved, a mutual recognition procedure can be initiated.

Applicant 

Manufacturers not established in the EAEU must appoint an Authorised Representative (AR) based in one of the member EAEU countries. This AR will act as the point of contact and will be responsible for the compliance of the device.

Registration times

They generally vary from 12 to 24 months, depending on the risk class of the device and the complexity of the documentation. Production site inspections can add up to 90 days to the process.

Validity of the EAEU Certificate

The EAEU Registration Certificate is valid indefinitely, unless there are significant regulatory changes or substantial changes to the device itself.

Documentation Language and Labelling

• Documentation: The main documentation must be submitted in Russian and/or Belarusian. Documentation in English is accepted if accompanied by a certified translation.
• Labelling and IFU (Instructions for Use): They must be provided in Russian and/or Belarusian.

Useful information

Possession of an EC certificate does not exempt one from registration under the EAEU system. However, technical documentation already prepared for CE marking can be partially reused by adapting it to the specific EAEU requirements.

At least one other Member State must indeed approve the registration in addition to the reference State, but in practice, manufacturers tend to involve several States from the outset to ensure automatic validity in the relevant markets.