Skip to main content

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.

Closing from 2027

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​

  1. The applicant submits the registration dossier to Roszdravnadzor
  2. Roszdravnadzor checks completeness and compliance with documentation requirements
  3. If complete, the dossier is forwarded to the FGBU National Institute of Quality for expert review
  4. The FGBU issues a formal opinion on whether a clinical investigation is needed
  5. Roszdravnadzor notifies the applicant of the Phase 1 outcome

Phase 2 — Clinical data submission and final review​

  1. If clinical investigation is required (or data is submitted from prior steps), the applicant submits clinical data to Roszdravnadzor
  2. Roszdravnadzor requests a second review from the FGBU National Institute of Quality
  3. The FGBU issues its expert opinion on whether the device may be approved
  4. 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 classApproximate timeline
Class I (standard)3–6 months
Class I (fast-track, sanction-impacted)5 working days
Class IIa6–12 months
Class IIb12–18 months
Class IIIUp to 24 months

Timelines often extend beyond these estimates. Common extension triggers include FGBU requests for additional information, clinical data, or QMS inspection scheduling delays. For innovative devices requiring full local clinical investigation, expect timelines of 3+ years for Class III.

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.

Official source

Government Decree No. 1684 (2025): government.ru
GRLS: grls.rosminzdrav.ru

Phase 1 — Dossier submission and initial review​

Clinical investigation requirements ​ The FGBU National Institute of Quality determines whether a clinical investigation is required based on:

  • Device novelty and innovation status
  • Availability of clinical data from equivalent devices already registered in Russia
  • Device class and intended use
  • Risk profile

For innovative devices with no registered equivalent in Russia, a full local clinical investigation conducted in approved Russian clinical centres is typically mandatory. This significantly extends timelines.

Phase 1 — Dossier submission and initial review​

Phase 1 completeness checks — common rejection reasons ​ Dossiers are most frequently rejected at Phase 1 for:

  • Missing or incomplete Russian translations
  • Power of Attorney lacking proper Apostille certification
  • Inadequate technical documentation per MOH Order No. 11
  • Missing or incomplete risk management file (GOST R ISO 14971)
  • Absence of ISO 13485:2016 certificate for required classes
  • Unclear intended purpose or indications for use

Ensure all documents are complete and properly certified before submission to avoid Phase 1 rejection.