Preliminary study on the application of digital medical supervision principle in software as a medical device in China
WANG Ying
Abstract：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.
Keywords：Digital healthRegulatory frameworkRegulatory principlesSoftware as a medical device
Publication Date：2024-04-28
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：8( 359-365,395 )