EAEU Registration Pathway
Overview
The EAEU (Eurasian Economic Union) registration pathway, governed by EEC Decision No. 46, provides a single Registration Certificate valid across all five EAEU member states: Russia, Belarus, Kazakhstan, Armenia, and Kyrgyzstan.
From 1 January 2027, this will be the only route available for new medical device registrations in Russia. Companies entering the market or approaching renewal should plan for EAEU registration from the outset.
EAEU member states
| Country | Competent authority |
|---|---|
| Russia | Roszdravnadzor |
| Belarus | Ministry of Health Belarus |
| Kazakhstan | Ministry of Health Kazakhstan |
| Armenia | Ministry of Health Armenia |
| Kyrgyzstan | Ministry of Health Kyrgyzstan |
How EAEU registration works
The EAEU pathway designates one member state as the reference state that conducts the primary review. Typically, Russia (Roszdravnadzor) acts as reference state for applications from foreign manufacturers with Russian-appointed representatives.
- The applicant selects a reference state and submits the EAEU dossier to that state's authority
- The reference state authority (e.g. Roszdravnadzor) conducts the expert review, involving EAEU-designated expert organisations
- The reference state issues an expert conclusion
- Other member states are notified and may raise concerns within a defined period
- The EEC issues the EAEU Registration Certificate
EAEU dossier requirements
The EAEU dossier follows the requirements set out in EEC Decision No. 46 and is broadly aligned with EU MDR-style technical documentation (Annex II), adapted for EAEU requirements. Key differences from the national route include:
- Structured common technical dossier format
- EAEU-specific expert organisation review (rather than FGBU alone)
- QMS inspection mandatory for Class IIb and III (mandatory from March 2019 under EAEU rules)
EAC marking
Devices registered under the EAEU pathway must bear the EAC mark (Евразийское соответствие — Eurasian Conformity). This mark must appear on the device label and packaging.
EEC Decision No. 46: eec.eaeunion.org
EAEU medical device database: eec.eaeunion.org