Preparing for the on-site examination of medical devices before NMPA registration in China is a critical step in the approval process. Here are the key points to consider:

1. Documentation Readiness

• Quality Management System (QMS): Ensure that your QMS documentation is complete, particularly compliance with ISO 13485. Include quality policies, procedures, and records.
• Device Specifications: Prepare detailed specifications, including design, materials, manufacturing processes, and intended use.
• Technical Files: Have technical files ready that include safety and efficacy data, labeling, and any previous regulatory submissions or approvals.

2. Facility Inspection

• Manufacturing Environment: Ensure the manufacturing site meets hygiene and safety standards. Regularly conduct internal audits to verify compliance.
• Equipment Calibration: All production and testing equipment should be properly calibrated and maintained, with records available for review.
• Control Measures: Document processes for managing environmental controls, including cleanliness, temperature, and humidity.

3. Product Samples

• Representative Samples: Prepare sufficient samples of the medical device for examination and testing. Ensure they represent the final product.
• Packaging and Labeling: Ensure that product packaging and labeling meet NMPA requirements, including correct usage instructions and warnings.

4. Personnel Training

• Staff Preparedness: Ensure that all personnel involved in the manufacturing process are well-trained and knowledgeable about the device and its regulatory requirements.
• Role Assignments: Designate key personnel to interact with the NMPA inspectors during the examination.

5. Compliance with Standards

• National Standards: Verify that the device complies with relevant Chinese national standards (GB standards) applicable to your medical device category.
• Testing Reports: Have all relevant testing reports ready, including biocompatibility, electrical safety, and performance testing.

6. Clinical Data

• Clinical Evaluation Reports: If applicable, prepare clinical evaluation reports that demonstrate the safety and effectiveness of the device based on clinical data or literature.

7. Risk Management

• Risk Analysis Documentation: Conduct and document a comprehensive risk analysis for the device, following ISO 14971 guidelines.
• Mitigation Strategies: Prepare risk mitigation plans for any identified risks.

8. Post-Market Surveillance Plans

• Monitoring Procedures: Develop and document procedures for post-market surveillance and vigilance reporting.
• Adverse Event Reporting: Ensure that you have a system in place for reporting adverse events to the NMPA.

9. Communication with NMPA

• Clarification of Requirements: Prior to the inspection, communicate with the NMPA to clarify any specific requirements or expectations.
• Be Transparent: Maintain transparency during the inspection process and be ready to answer any questions from inspectors.

10. Mock Inspections

• Conduct Mock Audits: Perform internal mock inspections to identify potential issues and areas for improvement before the actual examination.

Conclusion

Thorough preparation for the on-site examination can significantly enhance the likelihood of a successful NMPA registration process. By ensuring that documentation, product samples, and facility conditions are all in order, manufacturers can demonstrate their commitment to quality and compliance.

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