The assessment process and implementation rules for the safety review of Traditional Chinese Medicine (TCM) devices in the NMPA certification process in China involve several key steps:

1. Application Submission

• Documentation Requirements: Manufacturers must submit an application dossier that includes detailed information about the TCM device, including its intended use, design, manufacturing process, and safety data.
• Technical Documentation: This should encompass product specifications, labeling, and instructions for use.

2. Preliminary Review

• Administrative Review: NMPA conducts a preliminary review to ensure that the application is complete and complies with regulatory requirements.
• Acceptance of Application: If the application meets the initial criteria, it moves to the next stage; otherwise, the applicant may be asked to provide additional information.

3. Technical Review

• Safety Assessment: A comprehensive safety assessment is performed, focusing on the device's design, materials, and potential risks associated with its use.
• Compliance with Standards: The device must comply with relevant national standards (GB standards) and any specific TCM regulations.

4. Clinical Evaluation

• Clinical Data Submission: For devices requiring clinical data, manufacturers must submit evidence demonstrating safety and efficacy, including results from clinical trials or studies.
• Risk-Benefit Analysis: The clinical data must support a favorable risk-benefit ratio.

5. Expert Review

• Panel Evaluation: NMPA may convene expert panels to evaluate the technical and clinical data, providing recommendations on the device's safety and efficacy.
• Consultation with Experts: This step may involve consultations with professionals familiar with TCM practices and standards.

6. Post-Review Actions

• Approval or Rejection: Based on the assessments, the NMPA will approve or reject the application. If approved, a registration certificate will be issued.
• Conditions of Approval: The NMPA may impose conditions or requirements for post-market surveillance or additional studies.

7. Post-Market Monitoring

• Surveillance Obligations: Manufacturers must implement post-market surveillance to monitor the device's safety and effectiveness after it is on the market.
• Reporting Adverse Events: Any adverse events or safety concerns must be reported to the NMPA promptly.

Conclusion

The safety review process for TCM devices in the NMPA certification involves thorough documentation, rigorous safety assessments, expert evaluations, and ongoing post-market monitoring. Manufacturers must ensure compliance with all regulatory requirements to facilitate successful certification. For more detailed information, consult the NMPA's official guidelines on TCM devices.

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