Process for RZN Certification:

1. Prepare Documentation: Gather all necessary documents, including product specifications, technical descriptions, and quality management system information.

2. Submit Application: File your application with Roszdravnadzor, including the completed forms and all supporting documentation.

3. Review and Inspection: Roszdravnadzor will review the documents and may request additional information or conduct an inspection if required.

4. Certification Issuance: Once the review is complete and the device is found compliant, Roszdravnadzor will issue the certification.

Required Documents:

1. Application Form: Completed and signed.
2. Technical Documentation: Includes product specifications, technical data, and user manuals.
3. Quality Management System Documentation: Proof of compliance with relevant quality standards (e.g., ISO 13485).
4. Proof of Compliance: Documentation showing the device meets Russian safety and performance standards.
5. Product Samples: If required, provide samples for testing.

Considerations:

1. Language: Ensure all documents are translated into Russian or provide certified translations.
2. Regulatory Updates: Stay informed about any changes in Russian regulations that could impact your application.
3. Cost and Time: Be aware of potential costs and the time required for processing, which can vary based on the device and its complexity.

Would you like more details on any specific part of this process?

Contact Us：

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