In China, the National Medical Products Administration (NMPA) works with several designated auditing agencies to evaluate medical devices for certification. These agencies are responsible for conducting inspections and assessments of manufacturers and their quality management systems. Key auditing agencies include:
National Institutes for Food and Drug Control (NIFDC): This institute conducts tests and evaluations for medical devices and serves as a reference point for compliance with NMPA standards.
Registered Testing Laboratories: Various laboratories are authorized to perform testing on medical devices, including biocompatibility, safety, and performance testing. These laboratories must be recognized by the NMPA.
Third-Party Inspection Organizations: These organizations conduct audits of manufacturers' quality management systems, typically in accordance with ISO 13485 standards. They play a crucial role in the assessment process.
Provincial Food and Drug Administration (PFDA): Local agencies may also conduct audits and inspections as part of the NMPA's regulatory framework.
It’s essential to choose agencies that are accredited and recognized by the NMPA to ensure compliance with Chinese regulations.