Same Variety Products Comparison for the Clinical Trials Exemption

Which products can be exempted from clinical trial?
Under the CFDA regulation, the class I medical device and the products included 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 in China.

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.

The general requirements for the same variety products comparison to be exempted from clinical trials
The definition of the same variety products: The same variety products are the medical device with almost the same basic working principle, structural components, manufacturing materials(Active products is the skin contacting manufacturing material.), manufacturing techniques, performance requirements, safety evaluation, industry standards, intended use and etc. with the CFDA registered products. The differences among the declared products and the registered products will not have any effect on the product safety and effectiveness. These products can be define as the same variety products.

The method to determine the same variety products
The applicant analysis and evaluate the clinical trials or the data obtained during the clinical use of the the same variety products. It should approve the product safety and effectiveness. Also the applicant should approve the equality through the comparison of the declared products and the registered products.

Related links

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

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