Before applying for RZN certification of Class I medical devices, you should make the following preparations:

1. Understand Requirements: Familiarize yourself with the RZN certification requirements and relevant Russian regulations for medical devices.

2. Compile Technical Documentation: Gather all necessary technical documentation, including product specifications, technical descriptions, user manuals, and test results.

3. Ensure Quality Management System Compliance: Verify that your quality management system complies with standards like ISO 13485 and that all related documentation is up-to-date.

4. Translate Documents: Ensure that all required documents are translated into Russian if they are not already. Certified translations may be necessary.

5. Prepare Application Form: Complete the application form provided by Roszdravnadzor, ensuring accuracy and completeness.

6. Verify Product Testing: Ensure that your device has undergone all required testing and that you have documented evidence of compliance with relevant standards.

7. Review Labeling and Packaging: Ensure that your device’s labeling and packaging meet Russian requirements and include necessary compliance information.

8. Contact Roszdravnadzor: Reach out to Roszdravnadzor for any specific guidance or clarification on the application process and requirements.

Contact Us：

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