Yes, for NMPA registration in China, on-site audits are often required, particularly for higher-risk medical devices. The NMPA conducts these audits to ensure that the manufacturing facilities meet the necessary quality standards and regulatory requirements. The audit typically assesses the quality management system, production processes, and overall compliance with relevant standards.

The need for an on-site audit can depend on factors such as the device classification and whether the facility is already certified under an equivalent international quality management standard like ISO 13485. If you're preparing for NMPA registration, it's a good idea to ensure that your facility is ready for potential audits and adheres to the required quality standards.

If you need more details or have specific concerns about preparing for an audit, feel free to ask!

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