Registration Timelines
National pathway timelines
| Device class | Expected total timeline |
|---|---|
| Class I (standard) | 3–6 months |
| Class I (fast-track for sanction-impacted devices) | 5 working days |
| Class IIa (sterile) | 8–14 months |
| Class IIa (non-sterile) | 6–12 months |
| Class IIb | 12–18 months |
| Class III | 18–24 months |
These are approximate timelines for a complete, well-prepared dossier. Extensions commonly occur when:
- The FGBU requests additional information or clinical data
- Local clinical testing in Russia is required (adds several months)
- A manufacturing site QMS inspection is required (mandatory for IIa sterile, IIb, III from January 2024)
- Translation or Apostille issues delay acceptance
EAEU pathway timelines
EAEU timelines typically range from 12–24 months depending on device class and are broadly comparable to national timelines, though may extend due to coordination between EAEU member state expert organisations. Unlike the national pathway, there is no published statutory maximum review period for EAEU registration.
Innovative devices
For innovative devices — those with no registered equivalent in Russia — a full local clinical investigation must be conducted in approved Russian clinical centres, following National Ethics Committee approval. This adds significant time to the registration process, potentially extending total timelines to 3+ years for Class III devices.
Re-registration (renewal)
Re-registration of an expiring national registration must be initiated well in advance. Given the 2027 deadline, manufacturers should assess whether re-registration under EAEU rules is more appropriate.
Engage your Russian Authorized Representative (RUS REP) early — dossier preparation, translation, and QMS inspection scheduling all take significant lead time.
Add under 'Extensions commonly occur when':
- Additional post-market data is requested or becomes available during review
- Changes to related regulatory requirements occur during the review period
- Manufacturing site changes or QMS inspection re-scheduling is required