In China, several auditing agencies are recognized for conducting evaluations and audits related to NMPA (National Medical Products Administration) certification of medical devices. These agencies are primarily responsible for quality management system (QMS) audits, clinical evaluation assessments, and product testing. Here are some key auditing agencies:

1. National Institutes for Food and Drug Control (NIFDC)

• A key authority for testing and evaluating medical devices and pharmaceuticals, providing services for product testing and compliance assessment.

2. China National Center for Drug Evaluation (CNDE)

• Focuses on the review and evaluation of clinical data and applications for medical devices and drugs, ensuring they meet safety and efficacy standards.

3. Third-Party Testing Laboratories

• Numerous accredited laboratories are authorized to conduct testing for compliance with national standards (GB standards). These labs perform various tests, including safety, performance, and biocompatibility evaluations.

4. Certification Bodies

• Various certification bodies conduct audits for QMS compliance (ISO 13485) and other relevant standards. Examples include:
  • SGS China
  • Bureau Veritas
  • TÜV SÜD
  • Intertek

5. Local Regulatory Authorities

• Local branches of NMPA also perform audits and inspections for medical devices, especially for manufacturers located within their jurisdiction.

Final Notes

• It’s essential to select accredited and experienced agencies to ensure compliance with NMPA regulations effectively. Engaging with these agencies early in the process can help streamline the certification journey.