RZN certification is a process that ensures medical devices meet Russian standards for safety and effectiveness. For Class 2a devices, this certification is issued by the Federal Service for Surveillance in Healthcare (Roszdravnadzor).

Application Steps:

1. Prepare Documentation: Collect necessary documents such as technical specifications, clinical data, and manufacturing details.

2. Choose a Certification Body: Select an authorized Certification Body in Russia that handles RZN certifications.

3. Submit Application: Submit your documents and application to the chosen Certification Body.

4. Device Testing: Your device may undergo testing to confirm it meets Russian standards.

5. Review and Certification: The Certification Body reviews the application and testing results. Upon approval, you receive the RZN certification.