Clinical Assessment Requirements for the Clinical Trial Exampted Medical Devices

According to the regulation ‘Medical Device Clinical Assessment Technical guideline’ issued on May 19th 2015, the class II and III medical devices have to submit the clinical assessment in the CFDA medical device registration. And the product that 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.

Clinical Assessment Requirements for the Clinical Trial Exempted Medical Devices

• Submit comparison documents of the declared product related information and the content in the ‘catalogue’.
• Submit comparison explanation about the declared product and the CFDA registered products. The comparison explanation should include ‘The Comparison Chart of the Declared Product and the CFDA Registered Products’(see attachment 1) and relevant supporting documents. The required documents list above should approve the equality of the declared product and the product in the ‘catalogue’. If these can not approve the equality, it should follow the other direction in the ‘Medical Device Clinical Assessment Technical guideline’.

Attachment 1

The Comparison Chart of the Declared Product and the CFDA Registered Products

Note：Comparison items can be added based on the real situation.