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.
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