The audit content of NMPA (National Medical Products Administration) certification for medical devices in China is comprehensive and focuses on evaluating whether manufacturers comply with relevant regulations, quality management systems, and overall product safety and efficacy. Below is an outline of the key audit areas and content typically reviewed during the NMPA certification process:

1. Quality Management System (QMS)

• Document Review: Examination of the quality manual, standard operating procedures (SOPs), and other relevant documents to ensure they align with ISO 13485 and NMPA regulations.
• Implementation and Effectiveness: Assessment of how effectively the QMS is implemented throughout the organization, including training records and employee competencies.

2. Product Design and Development

• Design Controls: Evaluation of design processes, including design inputs, outputs, verification, validation, and design change controls.
• Technical Documentation: Review of technical files that include product specifications, intended use, design histories, and performance characteristics.

3. Risk Management

• Risk Analysis: Ensure compliance with ISO 14971, including risk assessment procedures, hazard identification, and risk control strategies.
• Risk Management File: Verification of the completeness and adequacy of the risk management documentation throughout the product lifecycle.

4. Manufacturing Processes

• Process Validation: Examination of manufacturing processes to ensure they are controlled and validated according to established procedures.
• Production Control: Assessment of controls in place to manage production, including equipment calibration, maintenance records, and manufacturing environment conditions.

5. Quality Control and Testing

• Incoming Material Inspection: Review of quality control measures for incoming materials and components.
• In-Process and Final Product Testing: Evaluation of sampling plans, testing results, and adherence to established acceptance criteria for the finished products.

6. Storage and Distribution

• Logistics Management: Inspection of warehousing and storage conditions to ensure compliance with regulatory requirements and product specifications.
• Traceability: Evaluation of system processes for tracking products and components through to final distribution to ensure adequate traceability.

7. Post-Market Surveillance

• Monitoring Procedures: Review of established post-market surveillance procedures, including how adverse events, complaints, and product performance are monitored and documented.
• CAPA (Corrective and Preventive Actions): Assessment of how the company handles non-conformities, including how CAPA systems are implemented and their effectiveness in addressing product issues.

8. Clinical Evaluation (for Class II and III Devices)

• Clinical Data Review: For devices requiring clinical evaluation, the audit will examine clinical trial protocols, ethics approvals, and data management.
• Clinical Evaluation Report: Review of ER for compliance with NMPA guidelines, ensuring that it substantively supports the device's safety and effectiveness claims.

9. Labeling and Packaging Compliance

• Labeling Review: Verification that labeling and instructions for use (IFU) comply with NMPA requirements and are clear, accurate, and informative.
• Packaging Checks: Assessment of packaging integrity, sterility (if applicable), and compliance with relevant standards.

10. Regulatory Compliance

• Adherence to Standards: Verification of compliance with Chinese national standards (GB standards) and any relevant international standards.
• Previous Audit Findings: Review of findings from any previous audits to ensure that identified issues have been addressed and resolved.

Conclusion

The NMPA audit for medical devices involves a multifaceted review of the manufacturer’s quality management systems, compliance with regulations, product safety and effectiveness, and overall operational processes. Each area of focus is crucial in ensuring that medical devices meet the necessary standards for certification.

For manufacturers, preparing for the NMPA audit involves comprehensive documentation and practice in quality management to demonstrate competence in all areas reviewed by the NMPA. If you have specific questions about the audit process, requirements for certain types of devices, or related topics, feel free to ask!

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