Yes, the NMPA registration of medical devices in China can include on-site audits as part of the evaluation process. During this on-site audit, NMPA representatives may review the manufacturing facilities, quality management systems, and compliance with regulatory standards and safety requirements.

These audits help ensure that the manufacturing practices align with the submitted documentation and standards, such as ISO 13485. The NMPA may conduct these audits when evaluating higher-risk medical devices or if there are concerns about the manufacturer’s compliance or product quality.

If you’d like more detailed information about the audit process or specific requirements, just let me know!

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