The audit content for NMPA-certified medical devices in China typically includes:

1. Quality Management System (QMS):

   • Compliance with ISO 13485: Verification of adherence to international quality management standards.
   • Document Control: Review of procedures for document creation, modification, and control.

2. Technical Documentation:

   • Device Specifications: Assessment of design, materials, and intended use.
   • Clinical Data: Examination of clinical trial results or studies supporting safety and efficacy.

3. Manufacturing Processes:

   • Production Facilities: Inspection of manufacturing sites for compliance with GMP (Good Manufacturing Practice) standards.
   • Process Control: Evaluation of production processes and quality control measures.

4. Safety and Performance Testing:

   • Test Reports: Review of safety and performance testing results, including risk management assessments.

5. Labeling and Instructions:

   • Compliance: Verification that labeling and user instructions meet NMPA requirements and are in Chinese.

6. Post-Market Surveillance:

   • Adverse Event Reporting: Assessment of the process for reporting and managing adverse events.
   • Market Feedback: Review of mechanisms for collecting and addressing customer feedback and complaints.

7. Regulatory Compliance:

   • Documentation: Ensure all regulatory documentation is complete and up-to-date.
   • Local Representation: Verification that a local agent or distributor is appointed and compliant with regulations.

These audits ensure that the device continues to meet regulatory standards and operates safely and effectively in the market.

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