Yes, the registration of medical devices in China requires a compliance review as part of the NMPA (National Medical Products Administration) certification process. This review ensures that the medical device meets all relevant technical, safety, and performance standards set by Chinese regulations. Here are the key aspects of the compliance review:

1. Documentation Assessment

The compliance review involves a thorough examination of the submitted documentation, including:

• Technical specifications of the device.
• Quality management system (QMS) certifications.
• Test reports demonstrating compliance with relevant standards.

2. Risk Management Evaluation

The review assesses how risks associated with the device have been identified and mitigated, in accordance with ISO 14971 standards. This includes evaluating the risk management file for completeness and accuracy.

3. Laboratory Testing

For many devices, especially those classified as Class II and III, the NMPA requires compliance testing conducted by accredited laboratories. The results must demonstrate that the device meets safety and performance criteria.

4. Clinical Evaluation

Higher-risk devices often require a clinical evaluation to support their safety and efficacy claims. This evaluation is part of the compliance review process.

5. On-Site Inspection

In some cases, an on-site inspection of the manufacturing facility may be conducted to verify adherence to Good Manufacturing Practices (GMP) and other regulatory requirements.

Conclusion

The compliance review is a critical component of the registration process for medical devices in China, ensuring that all aspects of the device meet regulatory standards before it can be marketed.

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