Russia
Russia is the largest healthcare market in Eastern Europe and a member of the Eurasian Economic Union (EAEU).
Do you require help or further information?
Contact us! We are happy to advise you:
Regulatory Framework
The competent authority is Roszdravnadzor, responsible for registration and surveillance.
Device Classification:
- Class 1: Low risk
- Class 2a, 2b: Moderate risk
- Class 3: High risk
Specific Local Requirements
| Language | Documentation in Russian. |
| Local Representative | Mandatory for foreign manufacturers. |
| Local Testing | Additional clinical trials may be required. |
Challenges and Operational Advice
- Variable timelines: The process can take up to 24 months.
- Local audits: Possible inspection of manufacturing facilities.
- Compliance: Testing must be adapted to Russian requirements.
Why Choose ISEMED
- DEDICATED SUPPORT
Assistance with clinical testing and managing a complex process. - LOCAL PARTNERS
Collaboration with Russian representatives to streamline timelines.
FAQ
- Is a local representative required? Yes.
- Documentation language? Russian.
- License duration? Unlimited, unless product updates occur.