To prepare documents for NMPA certification, follow these guidelines:

1. Application Form: Complete and sign the NMPA application form.
2. Device Description: Provide detailed information about the medical device, including its intended use, specifications, and design.
3. Clinical Data: Submit clinical trial data or literature reviews supporting the device's safety and effectiveness.
4. Manufacturing Information: Include details about the manufacturing process, quality control, and facilities.
5. Quality Management System: Document compliance with ISO 13485 or equivalent standards.
6. Labeling and Instructions: Provide labeling information and user manuals in Chinese.
7. Testing Reports: Include results from required safety and performance tests.
8. Authorization Letter: If applicable, include a letter of authorization from the device’s manufacturer.

Ensure all documents are translated into Chinese and notarized if necessary.