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数字疗法的应用、审批监管现状及展望

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随着数字医疗技术的快速发展,数字疗法作为医疗健康领域的一项创新应用,正逐渐成为疾病治疗和管理的重要手段.文章对数字疗法的定义、发展历史、典型应用等方面进行了介绍,重点分析总结了国内外相关医疗器械获证情况和监管体系现状,为我国规范完善审批监管体系、推动数字疗法健康发展提供借鉴.
Current Status and Perspectives on the Application,Regulatory Approval of Digital Therapeutics
With the rapid advancement of digital medical technology,digital therapeutics have emerged as an innovative application in the healthcare sector,progressively establishing themselves as a vital tool for disease treatment and management.This paper provides an introduction to the definition,historical development,and typical applications of digital therapeutics,with a particular focus on summarizing and analyzing the current status of medical device certification and regulatory frameworks both domestically and internationally.It aims to offer insights for the standardization and improvement of our country's approval and regulatory systems,thereby promoting the healthy development of digital therapeutics.

digital therapeuticstypical applicationsregistration approvalsupervision

安宇坤、王晨希

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中国食品药品检定研究院医疗器械检定所 (北京 102629)

数字疗法 典型应用 注册审批 监管

2024

中国医疗器械信息
中国医疗器械行业协会

中国医疗器械信息

影响因子:0.375
ISSN:1006-6586
年,卷(期):2024.30(15)