For RZN certification of Class I medical devices, the following conditions must be met:

1. Compliance with Standards: The device must meet Russian safety and performance standards as specified by Roszdravnadzor.

2. Quality Management System: You must demonstrate compliance with quality management standards, typically ISO 13485.

3. Technical Documentation: Provide comprehensive technical documentation, including product specifications, user manuals, and any necessary test results.

4. Valid Application: Submit a complete and accurate application form, including all required documents.

5. Proof of Manufacturer: Provide evidence of the manufacturer's registration and operational compliance.

6. Translation: Ensure all documents are translated into Russian if necessary.

Meeting these conditions ensures that your device is reviewed thoroughly and complies with Russian regulatory requirements.