On October 31st, the CFDA released and implemented the 3rd batch of “Medical Device Clinical Trial Exemption List”. There are 37 Class II, 11 Class III medical devices and 116 Class II IVD included on this list.
In the U.S., the medical device/IVD approval process is mature and well-developed, and 80% of medical devices/IVD can find referred predicate products and get exempted from clinical trial. But in China, there are 50% of medical devices/IVD that need to conduct clinical trials to complete their registration. To reform the medical device/IVD registration process and keep up with other western countries, the CFDA decided to issue several batches of the “Medical Device/IVD Clinical Trial Exemption List”
For new device registration in China, the manufacturer must first determine the device classification within the CFDA classification catalog. U.S. FDA classification does NOT correspond to that of CFDA. A U.S. FDA exempt device could be a Class II in China. Generally, a Class I device needs to file with the CFDA only. Most Class III devices need a clinical trial, especially if the devices are listed in the “Catalogue of Class III Medical Device that Needs Clinical Trial.
After you know the classification of your device in the CFDA classification system, check first to see if your device is on the clinical trial exempt list. Make sure that you refer to the newly updated 3rd batch of the clinical trial exempt lists
If your devices/IVD are on a clinical trial exemption list, you only need to submit the following clinical evaluation materials:
1. The comparison materials between your product information and the related content in the clinical trial exemption list
2. The comparison materials between your product and approved predicate product(s)
About China Med Device, LLC (CMD) CMD provides turn-key solution for Western medtech companies with regulatory and commercialization services. CMD helps its clients accelerate China entry and growth by offering: market Intelligence and research; CFDA regulatory services (premarket submission, clinical evaluation, clinical trial design & management, post market compliance and legal representation), and other commercial services. If you have an inquiry or feedback regarding our services please email us at info@ChinaMedDevice.com.