To obtain NMPA (National Medical Products Administration) certification for medical devices in China, a technical audit is typically required as part of the overall assessment process. Here are the general technical audit requirements:

1. Quality Management System (QMS) Audit: This audit assesses whether the manufacturer has implemented and maintains a QMS that complies with the relevant Chinese regulations, such as Good Manufacturing Practice (GMP) requirements for medical devices.

2. Product Technical Documentation Review: The technical documentation for the medical device is thoroughly reviewed to ensure compliance with Chinese regulatory requirements. This includes:

   • Design documentation, including specifications, drawings, and risk analysis.
   • Manufacturing processes documentation, such as procedures for production and quality control.
   • Clinical evaluation data (if applicable) to demonstrate the safety and performance of the device.

3. Sample Testing and Evaluation: Depending on the device classification and risk level, physical samples of the device may be subjected to testing to verify compliance with Chinese standards and specifications.

4. Facility Inspection: A physical inspection of the manufacturing facilities may be conducted to assess whether they meet the necessary standards for production and quality control.

5. Risk Management Audit: Evaluation of the manufacturer's risk management processes, including risk analysis and mitigation measures related to the medical device.

6. Clinical Evaluation Audit (if applicable): For certain types of medical devices, especially those with higher risk classifications, a review of clinical data and evaluations may be required to demonstrate the safety and effectiveness of the device.

7. Labeling and Packaging Review: Inspection of the device labeling and packaging to ensure they comply with Chinese labeling requirements and contain all necessary information in Chinese.

It's important to note that specific requirements can vary depending on the type of medical device and its classification according to the Chinese regulatory system. Manufacturers seeking NMPA certification often work closely with local regulatory consultants or authorized representatives in China to navigate these requirements effectively.