Yes, the NMPA registration process for medical devices in China can involve multiple quality inspections, especially for Class II and Class III devices. Here’s an overview of how these inspections typically play a role in the registration process:

1. Pre-Market Inspections

• On-Site Inspections: For certain Class II and III devices, the NMPA may conduct on-site inspections of the manufacturing facility. This is to ensure that the facility complies with Good Manufacturing Practices (GMP) and that the quality management system (QMS) is effectively implemented.
• Document Review: Inspections often include a thorough review of documentation related to quality management, manufacturing processes, and product specifications.

2. Testing and Verification

• Laboratory Testing: Before registration, manufacturers may be required to submit their devices for testing at designated laboratories. This testing verifies compliance with safety, performance, and efficacy standards.
• Testing Reports: The results from these laboratories must be included in the registration application. Any issues identified during testing must be addressed before proceeding with registration.

3. Quality Management System Evaluation

• ISO 13485 Compliance: Manufacturers are expected to demonstrate compliance with ISO 13485, which requires a systematic approach to quality management. This compliance may be assessed during inspections.
• Continuous Quality Monitoring: Even after initial registration, ongoing compliance with quality standards is monitored through routine inspections and audits by the NMPA or designated authorities.

4. Post-Market Inspections

• Surveillance Inspections: Once the device is on the market, the NMPA may conduct post-market surveillance inspections to monitor the quality and safety of the device in actual use.
• Adverse Event Reporting: Manufacturers must have systems in place to report any adverse events or quality issues that arise, which can trigger further inspections or investigations by the NMPA.

Conclusion

While Class I devices typically undergo a simpler record-filing process with less stringent inspection requirements, Class II and III devices face more rigorous scrutiny, including multiple quality inspections. Ensuring compliance with all regulatory requirements and maintaining high-quality standards throughout the manufacturing process is crucial for successful registration and market access in China. Manufacturers often benefit from working with local regulatory experts to navigate these complex requirements effectively.

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