CFDA issues Technical guideline for clinical evaluation of medical devices
China Food and Drug Administration (CFDA) recently issued the Technical Guideline for Clinical Evaluation of Medical Devices, which is applicable to the clinical evaluation of Class II and Class III medical device registration application, and inapplicable to the clinical evaluation of in vitro diagnostic reagents regulated as medical devices.
For more information, visit: http://www.sfda.gov.cn/WS01/CL0051/121425.html