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Clinical Trial Audit

According to the "Regulations on the Supervision and Administration of Medical Devices" (Order No. 739), Class I medical devices are subject to product filing management, and clinical trials are not required, but clinical evaluation data need to be submitted; when Class II and III medical devices are registered , clinical trials should be conducted (except for medical devices in the list of medical devices exempt from clinical trials); medical devices exempt from clinical trials must still provide clinical evaluation data when applying for registration.

Service Process:

 

Our Services and Time Distribution:

  • Audit preparation and on-site audit         within 1 month after receiving the project information
  • On-site audit                                               2 working days/institution
  • Audit report                                                 5 working days after all the on-site audits completed
  • CAPA plan review                                       3 working days after obtaining the CAPA plan
  • CAPA evidence review                               3 working days after obtaining the CAPA evidence