How to Determine if Clinical Trials Needed for Medical Device Registration in China

While applying for Medical Device initial registration, The Clinical Evaluation should be conducted according to the “Technical Guideline for Clinical Evaluation of Medical Devices”(CFDA Notice No. 14 2015). Clinical Evaluation shall be conducted via comparing with same variety medical device which has been approved in China or conducting clinical trials in local medical institutions designated by CFDA.

Confirm the Clinical Trial Requirements by Steps

Which product can be exempted from clinical trial?
The class I medical device or the product which listed in “the catalogue of Class II & III medical devices exempted from clinical trials” can be exempted from Clinical Trials while applying for medical device initial registration. For the medical device exempt from clinical trial, they are only required to submit the comparison information with the product already approved in China by comparing the application relative information and detailed contents in the catalogue and the comparing

Other two conditions can be exempted from local clinical trials as follows:

The product already conducted clinical trial according to China GCP of medical device (CFDA order No. 25 2016) or;
The product whose same variety product’s clinical and technical information can be acquired via authorization.

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