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