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)
- 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.