The procedure and standards for the background investigation of traditional Chinese medicine (TCM) device enterprises during the NMPA (National Medical Products Administration) certification process in China involve several systematic steps and requirements. Here's a comprehensive overview:

1. Preliminary Assessment

Before initiating the formal certification process, enterprises often complete a self-assessment to determine their readiness. This includes evaluating compliance with essential requirements such as legal status, quality management systems, and technical capabilities.

2. Application Submission

The enterprise must submit an application package that includes:

• Business License: Proof of valid registration and legal status in China.
• Quality Management System Documentation: Evidence of compliance with ISO 13485 or relevant QMS standards.
• Product Information: Detailed descriptions of the TCM devices, including intended use, technical specifications, and risk classification.

3. Document Review

NMPA will conduct a thorough review of the submitted documentation, which typically includes:

• Documentation of the Quality Management System with procedures, accounts of audits, and corrective actions taken.
• Technical files that include design history, safety and efficacy data, and clinical evaluation reports.
• Records of personnel qualifications and training programs.

4. Background Investigation and Verification

During the background investigation, NMPA will review the following aspects:

• Manufacturing and Operational Capabilities: Assessment of physical facilities, equipment, processes, and overall manufacturing capabilities to ensure they meet Good Manufacturing Practices (GMP) standards.
• Personnel Competence: Verification of qualifications and training of key personnel involved in design, manufacture, and quality control processes.
• Financial Stability: Evaluation of the enterprise’s financial health to ensure it has the resources to maintain compliance.
• Compliance Record: Review any prior compliance issues, violations, or recalls associated with the manufacturer, as well as any interactions with regulatory authorities.
• Reputation: Assessment of the enterprise's reputation in the medical device industry, including any reports or records of quality complaints or legal disputes.

5. On-site Inspection

If deemed necessary, NMPA may conduct an on-site inspection of the manufacturing facility to ensure compliance with regulatory requirements and verify the information submitted in the application. During the inspection, NMPA focuses on:

• Manufacturing processes and quality control measures.
• Product testing laboratories and data integrity.
• Documentation and record-keeping practices.

6. Post-Market Surveillance Plan

Enterprises must submit a plan detailing how they will monitor their products after reaching the market. This includes how they will handle adverse events and complaints, as well as data collection methods for ongoing safety assessments.

7. Standards and Guidelines Compliance

Enterprises must adhere to specific standards and guidelines related to TCM medical devices. This may include:

• Relevant Chinese national standards (GB standards).
• Industry standards specific to TCM practices and devices.
• Compliance with any specific technical requirements outlined for TCM devices by NMPA.

8. Final Review and Certification

Based on the documentation, inspection results, and investigation findings, NMPA will conduct a final review. If the enterprise meets all the necessary requirements and standards, the certification for the TCM medical devices will be granted.

Conclusion

Entering the certification process for TCM devices with NMPA requires thorough preparation and compliance with regulatory standards, which cover various dimensions of manufacturing and operational practices. Regular engagement with regulatory consultants and continuous improvement of processes are recommended to facilitate successful certification.

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