Third batch of products exempted from clinical trials published

The CFDA published a third list of medical devices and IVD that is exempted from mandatory clinical trials.

The publication lists

• 11 Class III products
• 37 Class II products

that will no more require clinical trials in China.

The publication 2017年第170号 is only available in Chinese.

The first batch  issued in 2014 exempted already:

• 112 Class III Products and
• 488 Class II products ( 2014年　第12号)

and the second batch published as 2016年第133号 further:

• 92 Class III products
• 267 Class II products

We are currently preparing the consolidated list of products exempted from clinical trials. feel so free to Contact us.