For NMPA-registered medical devices in China, on-site review requirements and the implementation plan generally involve the following aspects:

On-Site Review Requirements

1. Class I Devices:

   • Typically, on-site inspections are not required for Class I medical devices. The registration process primarily involves document review.

2. Class II and Class III Devices:

   • On-site inspections are more common for Class II and Class III medical devices. These inspections assess the manufacturing facility’s quality management system, compliance with regulatory standards, and overall product safety and efficacy.

On-Site Review Implementation Plan

1. Preparation for Inspection:

   • Facility Readiness: Ensure that the manufacturing facility is compliant with Good Manufacturing Practices (GMP) and NMPA regulations.
   • Documentation: Prepare all necessary documentation, including quality management system records, production processes, and product testing results.
   • Internal Audit: Conduct an internal audit to ensure all processes and records are in order before the inspection.

2. During the Inspection:

   • Compliance Check: Inspectors will review the manufacturing processes, quality control procedures, and documentation to ensure they meet NMPA standards.
   • Product Sampling: Inspectors may take samples of the device for testing to verify that it meets safety and performance criteria.

3. Post-Inspection Actions:

   • Address Findings: If the inspection identifies any non-compliance issues or areas for improvement, the manufacturer will need to address these findings and submit corrective action plans.
   • Follow-Up Inspection: In some cases, a follow-up inspection may be required to verify that corrective actions have been implemented.

4. Implementation Plan for Corrective Actions:

   • Develop Plan: Create a detailed plan to address any issues identified during the inspection. This should include timelines, responsible personnel, and specific actions to be taken.
   • Monitor Progress: Regularly monitor the progress of corrective actions to ensure they are completed effectively.
   • Report to NMPA: Submit a report to the NMPA outlining the corrective actions taken and any updates made to the facility or processes.

Maintaining a high level of compliance and preparedness can help ensure a smooth review process and ongoing regulatory approval for medical devices in China.