The regulatory requirements and operational procedures for the safety review of NMPA-certified medical devices in China involve several key components:

1. Regulatory Framework

• NMPA Guidelines: Familiarize yourself with the NMPA's regulations and guidelines specific to medical devices, including the Medical Device Supervision and Administration Regulations.
• Standard Compliance: Ensure compliance with national standards (GB standards) related to safety and performance.

2. Pre-Market Safety Assessment

• Risk Management: Implement a risk management process according to ISO 14971 to identify, assess, and mitigate risks associated with the medical device.
• Safety Testing: Conduct preclinical and clinical testing to evaluate safety, efficacy, and performance. Testing should be carried out by accredited laboratories.

3. Submission of Safety Data

• Technical Documentation: Prepare and submit a comprehensive technical file, including:
  • Device description and intended use.
  • Risk management documentation.
  • Test reports demonstrating compliance with safety standards.
• Clinical Evaluation Report: Provide a clinical evaluation report summarizing the safety and effectiveness data collected.

4. NMPA Review Process

• Document Review: The NMPA will review submitted documents to assess safety, quality, and effectiveness.
• On-site Inspection: The NMPA may conduct on-site inspections of manufacturing facilities to evaluate compliance with quality management systems and safety standards.

5. Post-Market Surveillance

• Monitoring Requirements: After certification, implement a post-market surveillance system to monitor device safety and report adverse events.
• Periodic Reporting: Submit periodic safety update reports to the NMPA, including data on adverse events and product performance.

6. Corrective and Preventive Actions (CAPA)

• Response Plans: Develop procedures for addressing safety issues, including corrective and preventive actions in case of device malfunctions or adverse events.

7. Training and Compliance

• Staff Training: Ensure that all staff involved in safety reviews are trained on regulatory requirements and procedures.
• Continuous Compliance: Regularly update processes and documentation to comply with any changes in NMPA regulations.

Adhering to these requirements and procedures is crucial for ensuring the safety and effectiveness of medical devices in the Chinese market.

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