For RZN certification of Class I medical devices, the technical document requirements generally include:

1. Product Specifications: Detailed descriptions of the device, including design, functionality, and intended use.

2. Technical Data: Information on the materials used, manufacturing processes, and any safety or performance testing results.

3. User Manual: Instructions for proper use, maintenance, and any safety warnings.

4. Quality Management System Documentation: Evidence of compliance with relevant quality management standards, such as ISO 13485.

5. Labeling Information: Details on labeling and packaging, including product labels, instructions for use, and any compliance marks.

6. Conformity Assessment Reports: Reports demonstrating that the device meets relevant safety and performance standards.

Ensure that all documents are translated into Russian if necessary and adhere to Roszdravnadzor’s specific requirements.

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