During the NMPA (National Medical Products Administration) certification process in China, the technical qualification requirements for medical devices typically include:

1. Technical Documentation: Comprehensive technical documentation demonstrating compliance with relevant standards and regulations.

2. Testing and Validation: Evidence of testing and validation conducted according to Chinese national standards or equivalent international standards.

3. Clinical Evaluation: Clinical data and evaluation reports, especially for higher-risk devices, demonstrating safety and efficacy.

4. Quality Management System (QMS): Implementation of a robust QMS that conforms to ISO 13485 standards or its Chinese equivalent.

5. Labeling and Instructions for Use: Accurate and compliant labeling and instructions for use (IFU) in Chinese.

6. Risk Management: Documentation of risk management processes and assessments throughout the device lifecycle.

7. Manufacturing Site Inspection: Depending on the classification of the device, inspections of manufacturing facilities may be required.

These requirements ensure that medical devices meet Chinese regulatory standards and are safe and effective for use in the Chinese market.

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