The background investigation of enterprises applying for NMPA (National Medical Products Administration) certification for Traditional Chinese Medicine (TCM) devices involves several key procedures and standards. Here’s an overview:

1. Application Submission

• Preliminary Documents: Submit required documents, including business licenses, organizational structures, and quality management system certifications (e.g., ISO 13485).
• Product Information: Detailed information about the TCM device, including specifications, intended use, and manufacturing processes.

2. Enterprise Qualification Review

• Legal Status Verification: Ensure the company is legally registered and compliant with Chinese regulations.
• Financial Stability: Assess the financial health of the enterprise through financial statements, tax records, and other relevant documents.

3. Quality Management System (QMS) Evaluation

• Compliance with QMS Standards: Verify adherence to quality standards relevant to medical devices, particularly ISO 13485 or equivalent.
• Documentation Review: Evaluate the quality manual, standard operating procedures (SOPs), and records of quality control.

4. Technical Capability Assessment

• R&D and Production Facilities: Inspect the adequacy of research and development capabilities, as well as production facilities. This includes evaluating equipment, technology, and personnel qualifications.
• Testing and Validation: Ensure that the enterprise has facilities for adequate testing of the TCM devices, including efficacy and safety assessments.

5. Product History and Market Presence

• Sales Data: If applicable, provide evidence of previous sales, market presence, and customer feedback for existing products.
• Clinical Data: For devices that have undergone clinical trials, submit clinical trial data demonstrating safety and efficacy.

6. Compliance with Regulatory Standards

• Adherence to National Standards: Ensure that the TCM device complies with relevant Chinese national standards (GB standards) and industry-specific regulations.
• Documentation of Certifications: Provide any existing certifications, such as CE marking or FDA clearance, if applicable.

7. On-Site Inspection

• NMPA Evaluation Team Visit: An NMPA evaluation team may conduct on-site inspections to assess compliance with the submitted documentation and operational practices.
• Interviews: Interviews with key personnel may be conducted to evaluate understanding of regulatory requirements and quality practices.

8. Final Assessment and Approval

• Compilation of Findings: The evaluation team compiles findings and makes a recommendation regarding the application.
• NMPA Decision: The NMPA reviews the recommendations and makes a final decision regarding certification.

Conclusion

The background investigation process for TCM device enterprises is thorough, focusing on compliance with regulatory standards, quality management practices, and the enterprise’s ability to produce safe and effective medical devices. It's crucial for enterprises to maintain robust documentation and be prepared for both documentary and on-site evaluations to ensure a smooth certification process.

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