The technical audit requirements for NMPA (National Medical Products Administration) certification in China are designed to ensure that medical devices meet safety, efficacy, and quality standards. Below are the key components of the technical audit requirements:

1. Quality Management System (QMS) Compliance

• ISO 13485 Certification: Manufacturers must establish and maintain a QMS compliant with ISO 13485 standards, which outlines requirements for a comprehensive quality management framework.
• Documentation and Records: The QMS documentation should include policies, procedures, work instructions, and records that demonstrate compliance with the regulatory requirements.

2. Design Control

• Design and Development Process: Documentation must show how the design is developed, including design inputs, outputs, verification, and validation processes.
• Risk Management: A documented risk management process should be in place, following ISO 14971, which identifies potential hazards and evaluates risks associated with the medical device.

3. Production and Process Controls

• Manufacturing Processes: Documentation of manufacturing processes should demonstrate consistency and control, including process validation and changes management.
• Supplier Quality Management: Evidence of control over suppliers and outsourced processes, including supplier qualification and monitoring.

4. Preclinical and Clinical Evaluation

• Clinical Data: Providers must present clinical evaluation reports or data supporting the safety and performance of the medical device as part of the technical documentation. This might include clinical trials or studies, particularly for Class II and III devices.
• Preclinical Testing: Requirements for preclinical evaluations to show data supporting the device's biocompatibility and performance characteristics.

5. Product Testing and Compliance

• Testing Reports: Manufacturers must submit test reports from accredited laboratories demonstrating compliance with Chinese national standards (GB standards) or other recognized international standards applicable to the device.
• Performance Standards: Ensure that the device meets relevant performance standards, including electrical safety, electromagnetic compatibility (EMC), and specific functional parameters.

6. Labeling and Instructions for Use

• Labeling Requirements: The labels and instructions for use must be compliant with NMPA requirements, including being in Chinese and containing all necessary information such as usage instructions, safety warnings, and contraindications.

7. On-Site Inspection

• Facility Inspection: NMPA may conduct an on-site inspection of the manufacturing facility for Class II and III medical devices to ensure compliance with QMS and manufacturing standards.
• Audit Duration: The length of the audit can vary depending on the complexity of the device and the findings during the audit.

8. Post-Market Surveillance System

• Implementation of PMS: A plan for post-market surveillance should be established to monitor the device's performance in the market.
• Adverse Event Reporting: Procedures for reporting and managing adverse events must be documented and demonstrated during the audit.

Conclusion

The technical audit requirements for NMPA certification involve a thorough review of the manufacturer's quality management systems, product development processes, testing compliance, and post-market surveillance plans. Successful audits depend on accurate documentation, adherence to standards, and evidence of the device's safety and effectiveness.

If you need specific details regarding a particular type of device or situation, feel free to ask!

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