31. October 2017

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...