China Will Expand Clinical Trial Requirements, Emphasizing Higher-Risk Devices-thegraysheet: China FDA will officially require most Class 2 and Class 3 devices to conduct a clinical program in China to support regulatory approval starting in October under a new regulation. CFDA has previously issued regulations on conducting clinical trials for medical devices, but the new rule represents a more comprehensive approach to clinical trial requirements. Class 2 devices are categorized as those with relatively low risk while Class 3 products are implanted in the body or used to sustain or support life.
