Yes, NMPA (National Medical Products Administration) registration in China requires compliance certification. This certification demonstrates that medical devices meet the relevant Chinese regulatory requirements for safety, efficacy, and quality. Key aspects of compliance include:

1. Technical Documentation: Comprehensive documentation showing conformity to Chinese standards and regulations.

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

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

4. Quality Management System (QMS): Implementation of a QMS that complies with ISO 13485 or its Chinese equivalent.

5. Labeling and Instructions for Use: Correct and compliant labeling and IFU in Chinese.

6. Risk Management: Documentation of risk management processes and assessments.

7. Manufacturing Site Inspection: Inspections of manufacturing facilities, depending on the device classification.

Compliance certification is essential for obtaining NMPA registration, ensuring that medical devices meet regulatory requirements for sale and distribution in China.

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