To obtain RZN certification for Class I medical devices, follow these steps:

1. Understand Requirements:

   • Review Russian regulations and standards for medical devices, including Technical Regulation TR TS 020/2011.
   • Ensure compliance with quality management standards such as ISO 13485.

2. Prepare Documentation:

   • Technical Documentation: Include product specifications, technical descriptions, user manuals, and safety test results.
   • Quality Management System: Provide evidence of compliance with relevant quality management standards.
   • Labeling Information: Prepare and verify that labeling and packaging meet Russian requirements.

3. Translate Documents:

   • Ensure all required documents are translated into Russian if necessary, using certified translations.

4. Complete Application Form:

   • Obtain the application form from Roszdravnadzor, either from their website or office.
   • Fill out the form accurately, ensuring all information is complete.

5. Submit Application:

   • Submit the completed application form along with all supporting documentation to Roszdravnadzor. This can be done electronically or in person.

6. Review and Inspection:

   • Roszdravnadzor will review the application and documentation. They may request additional information or conduct an inspection if needed.

7. Receive Certification:

   • If the review is successful and the device meets all requirements, Roszdravnadzor will issue the certification for your Class I medical device.

8. Post-Certification Compliance:

   • Maintain ongoing compliance with Russian regulations and standards. Implement post-market surveillance to monitor the device’s performance and report any issues.

Ensuring thorough preparation and adherence to regulatory requirements will help streamline the certification process.

Contact Us：

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