Medical Devices Registration in Russia

Selling medical devices in Russia requires formal registration with the national health authority — Roszdravnadzor. This process involves in-depth evaluation of product safety, quality, and clinical performance. Whether you are a global manufacturer or a regional distributor, we help you successfully navigate Russian regulatory requirements.

1. Preliminary classification
   The product is classified according to risk level based on Order No. 4n. Risk level determines the scope of testing and documentation.
    
2. Document preparation
   The registration dossier must include technical, toxicological, and clinical documentation — all prepared in accordance with the new standards.
    
3. Testing in accredited Russian labs
   All devices must undergo local technical and biocompatibility testing. Foreign protocols (e.g., CE or FDA) may be submitted as supportive material but do not replace local requirements.
    
4. Clinical evaluation or trials
   Depending on the risk class and device type, a clinical evaluation or trial may be required within Russian medical institutions.
    
5. Expert review and certificate issuance
   Once the review is complete and the device is deemed compliant, a national registration certificate is issued by Roszdravnadzor.

We manage the full registration cycle for you, including:

• Risk classification and regulatory strategy
   
• Preparation and review of the full technical dossier
   
• Coordination of local testing and clinical stages
   
• Certified and notarized translations
   
• Legal support and documentation for Roszdravnadzor submission
   
• Post-registration support (e.g., amendments, renewals)

The Russian medical device market is large, fast-moving, and full of opportunity — if approached correctly. Let us guide you through the process.

Contact us at: info@lb-med.com