The background investigation for Traditional Chinese Medicine (TCM) device enterprises during NMPA certification in China involves several key procedures and standards:

1. Documentation Submission: Enterprises must submit comprehensive documentation, including business licenses, quality management system certifications (e.g., ISO 13485), and product technical documents.

2. Site Inspection: The NMPA may conduct on-site inspections of the manufacturing facilities to assess compliance with Good Manufacturing Practices (GMP) and evaluate production capabilities.

3. Quality Management System Review: Evaluation of the enterprise’s quality management system to ensure adherence to regulatory standards, particularly concerning safety and efficacy.

4. Background Checks: The NMPA will verify the legitimacy and compliance history of the enterprise, including checking for any past regulatory violations or quality issues.

5. Clinical Evidence Review: If applicable, the enterprise must provide clinical data demonstrating the safety and efficacy of the TCM devices, adhering to relevant standards.

6. Expert Evaluation: A panel of experts may review the submitted materials and inspection reports to ensure compliance with technical and regulatory standards.

Enterprises should stay updated on NMPA guidelines, as requirements may change, and it’s beneficial to engage with regulatory consultants for detailed guidance.

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