新兴技术的发展，推动数字疗法逐渐流行，软件已成为医疗产品的重要组成部分。根据国际医疗器械监管机构论坛的定义，SaMD(software as a medical device)是指"具有一个或多个医疗用途，且无需医疗器械硬件即可完成预期用途的软件"，但由于国内外尚无对其完整全面的评估与监管体系，其监管问题亟须加强监管研究。本文通过介绍SaMD相关概念及政策、人工智能背景下SaMD面临的监管挑战、我国和WHO对数字医疗的管理原则等情况，使读者获悉为加强SaMD审评与监管的思路，以期对完善我国SaMD监管原则提供启示。
Preliminary study on the application of digital medical supervision principle in software as a medical device in China
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.
Digital healthRegulatory frameworkRegulatory principlesSoftware as a medical device
国家科技期刊平台
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