National vs EAEU — Overview
Two pathways
Foreign and domestic manufacturers registering a medical device for the Russian market can use one of two pathways:
| National Route | EAEU Route | |
|---|---|---|
| Governing instrument | Government Decree No. 1684 (2025) | EEC Decision No. 46 |
| Geographic validity | Russia only | Russia + Belarus + Kazakhstan + Armenia + Kyrgyzstan |
| Submission deadline | Closes to new submissions from 1 Jan 2027 | The route going forward |
| Expert review | FGBU National Institute of Quality | EAEU-designated expert organisations |
| Certificate name | RZN Registration Certificate | EAEU Registration Certificate |
| Clinical testing | Often required in Russia | Often required in Russia |
| QMS inspection | Mandatory for IIa sterile, IIb, III | Mandatory for IIb, III (from March 2019) |
Which route should I use?
- Entering Russia for the first time — use the EAEU pathway. It provides broader market access and is the only route available from 2027 onwards.
- Existing national registration — valid until expiry. Plan for EAEU re-registration in advance of the 2027 deadline.
- Entering multiple EAEU markets — EAEU registration is strongly preferred as it covers all five markets.
Deadline: January 2027
From 1 January 2027, Roszdravnadzor will stop accepting new registration submissions under the national (Decree No. 1684) pathway. All new registrations must be submitted under EAEU rules. Existing national registrations remain valid until their stated expiry date but cannot be renewed under national rules after this date.
Plan ahead
If your device's national registration expires after 2027, begin EAEU registration preparations now. The EAEU registration process typically takes 12–24 months depending on device class.