To obtain RZN certification for Class 2a medical devices in Russia, you need to meet several requirements:

1. Technical Documentation:

   • Detailed device description and specifications.
   • Intended use and user instructions.
   • Evidence of compliance with applicable international standards.

2. Clinical Data:

   • Clinical trials or studies demonstrating the safety and efficacy of the device.
   • Clinical evaluation reports if applicable.

3. Quality Management System:

   • Documentation of the manufacturing process and quality control measures.
   • Evidence of adherence to Good Manufacturing Practices (GMP).

4. Product Testing:

   • Results from testing that confirms the device meets Russian standards and regulations.
   • Testing may be required for safety, performance, and electromagnetic compatibility.

5. Regulatory Documentation:

   • Proof of compliance with other relevant regulations or standards.
   • Copies of certifications or approvals from other countries if available.

6. Labeling and Packaging:

   • Labels and packaging must be compliant with Russian language requirements and regulatory guidelines.

7. Application Submission:

   • Complete application form and submission to an authorized Certification Body in Russia.

8. Fees:

   • Payment of any applicable certification fees to the Certification Body.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn