The inspection items for NMPA-certified medical devices focus on ensuring compliance with safety, quality, and regulatory standards. Here’s an overview of the key inspection items:
1. Quality Management System (QMS)
- Evaluation of compliance with ISO 13485 or equivalent standards.
- Review of documented procedures and records related to quality control.
2. Manufacturing Facility
- Inspection of production areas for cleanliness, organization, and proper equipment maintenance.
- Assessment of environmental controls, including temperature and humidity monitoring.
3. Personnel Qualifications
- Verification of staff training records and qualifications.
- Assessment of roles and responsibilities in the manufacturing process.
4. Production Process
- Examination of the manufacturing process, including:
- Raw material sourcing and specifications.
- Production methods and controls.
- In-process testing and validation.
5. Product Testing and Compliance
- Review of pre-market and post-market testing results.
- Verification of compliance with relevant national and international standards.
6. Documentation and Records
- Inspection of design and technical files, including risk management documentation.
- Review of change control processes and documentation of non-conformities.
7. Clinical Evaluation (if applicable)
- Evaluation of clinical data supporting safety and efficacy.
- Review of clinical trial protocols and results.
8. Post-Market Surveillance
- Assessment of systems for monitoring product performance post-approval.
- Review of adverse event reporting and corrective actions taken.
9. Labeling and Instructions for Use
- Inspection of product labeling for compliance with NMPA requirements.
- Verification of clarity and accuracy in instructions for use.
Conclusion
These inspection items aim to ensure that medical devices meet safety and efficacy standards throughout their lifecycle. A thorough preparation process and adherence to regulatory requirements are essential for successful NMPA certification.
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