Medical Devices
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Medical Devices
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Clinical Trial Documentation Preparation

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:

  • Clinical trial protocol                        20 working days

  • Informed consent form                    5 working days

  • Clinical trial summary report           20 working days

  • Clinical evaluation report                 20-120 working days

  • Investigator’s brochure        10 working days

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