药学研究2024，Vol.43Issue(4)：359-365,395,8.DOI:10.13506/j.cnki.jpr.2024.04.009
我国数字医疗监管原则在独立软件医疗器械的应用初探
Preliminary study on the application of digital medical supervision principle in software as a medical device in China
王颖1
作者信息
- 1. 上海市药品和医疗器械不良反应监测中心,上海 200040
- 折叠
摘要
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.关键词
数字健康/监管框架/监管原则/医疗器械/独立软件Key words
Digital health/Regulatory framework/Regulatory principles/Software as a medical device分类
药学引用本文复制引用
王颖..我国数字医疗监管原则在独立软件医疗器械的应用初探[J].药学研究,2024,43(4):359-365,395,8.
