我国数字医疗监管原则在独立软件医疗器械的应用初探OACSTPCD

The development of emerging technologies has promoted the popularity of digital therapy,and software has become an important part of medical products.The International Medical Device Regulators Forum(IMDRF)defines'soft-ware as a medical device(SaMD)'as software intended to be used for one or more medical purposes that perform these pur-poses without being part of a hardware medical device.However,due to the lack of a complete and comprehensive evaluation and supervision system at home and abroad,it is urgent to strengthen supervision research on its supervision.This paper in-troduced the related concepts and policies of SaMD,the regulatory challenges faced by SaMD under the background of artifi-cial intelligence,and the management principles of digital medical care in China and WHO,so as to inform readers of the i-deas for strengthening the review and supervision of SaMD,with a view to providing enlightenment for improving the regula-tory principles of SaMD in China.