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The essential document for applying for NMPA certification (formerly known as CFDA certification) in China typically includes:

1. Technical Documentation: This includes detailed information about the design, manufacturing process, materials used, and performance characteristics of the medical device.

2. Clinical Evaluation Report: Depending on the risk classification of the device, clinical data and evaluation reports demonstrating safety and efficacy may be required.

3. Quality Management System (QMS) Documentation: Evidence of compliance with ISO 13485 or equivalent quality management standards.

4. Device Testing Reports: Testing reports from accredited laboratories demonstrating compliance with relevant standards, such as GB standards for medical devices.

5. Labeling and Instructions for Use (IFU): Comprehensive labeling information in Chinese and IFUs that are clear and compliant with local regulations.

6. Manufacturing License: For manufacturers outside China, a copy of the Manufacturing License issued by the regulatory authority in the country of origin may be required.

7. Authorized Representative Documents: If applicable, documents appointing an authorized representative in China.

These documents are crucial for demonstrating compliance with NMPA regulations and ensuring a smooth certification process in China.

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