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:

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.

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