CFDA issues Guideline for Technical Review of Medical Device Software Registration
On August 5, 2015, China Food and Drug Administration (CFDA) issued the Guideline for Technical Review of Medical Device Software Registration. The Guideline is for guiding manufacturers to submit application documents of medical device software registration and standardizing the technical review requirements for medical device software.
For more detail, please visit Chinese version of CFDA website: http://www.sfda.gov.cn/WS01/CL0087/126243.html