National Registration Pathway
Overview
The national registration pathway is governed by Government Decree No. 1684, which came into force on 1 March 2025, replacing the previous Decree No. 1416 (in force since 2012). The new Decree aligns documentation requirements more closely with EAEU standards and introduces clearer rules for manufacturing site inspections.
New submissions under the national pathway close from 1 January 2027. Plan to use the EAEU pathway for all new registrations.
Who can apply
The application must be submitted by either:
- A Russian manufacturer — applying on their own behalf
- A Russian Authorized Representative (RUS REP) — acting on behalf of a foreign manufacturer
Foreign manufacturers cannot submit applications directly.
The two-phase process
Registration proceeds in two phases:
Phase 1 — Dossier submission and initial review
- The applicant submits the registration dossier to Roszdravnadzor
- Roszdravnadzor checks completeness and compliance with documentation requirements
- If complete, the dossier is forwarded to the FGBU National Institute of Quality for expert review
- The FGBU issues a formal opinion on whether a clinical investigation is needed
- Roszdravnadzor notifies the applicant of the Phase 1 outcome
Phase 2 — Clinical data submission and final review
- If clinical investigation is required (or data is submitted from prior steps), the applicant submits clinical data to Roszdravnadzor
- Roszdravnadzor requests a second review from the FGBU National Institute of Quality
- The FGBU issues its expert opinion on whether the device may be approved
- If the opinion is positive, Roszdravnadzor adds the record to the GRLS and issues the Registration Certificate
Key documents in the dossier
- Power of Attorney with Apostille stamp (from foreign manufacturer to RUS REP)
- Technical documentation per Decree No. 1684 / MOH Order No. 11 requirements
- ISO 13485:2016 Certificate (mandatory for Class IIa sterile, IIb, III)
- Pre-clinical and clinical evaluation reports
- Labelling and instructions for use in Russian
- All documents translated into Russian by a certified translator
Timelines by class
| Device class | Approximate timeline |
|---|---|
| Class I (standard) | 3–6 months |
| Class I (fast-track, sanction-impacted) | 5 working days |
| Class IIa | 6–12 months |
| Class IIb | 12–18 months |
| Class III | Up to 24 months |
Timelines may extend if the FGBU requests additional information or clinical data.
The Registration Certificate
On approval, a Registration Certificate is issued and the device is entered into the GRLS database. The certificate includes the device name, manufacturer details, class, intended purpose, and validity period. The certificate must be kept current — any changes to the device or labelling must be notified to Roszdravnadzor.
Government Decree No. 1684 (2025): government.ru
GRLS: grls.rosminzdrav.ru