As a recognized and effective decision-making assessment tool, health technology assessment can provide scientific support for scientific decision-making such as medical devices deployment and management. This study highlighted the necessity of medical device health technology assessment by studying the development history of health technology assessment at home and abroad. On this basis, the authors pointed out the necessity of medical device health technology assessment from the perspective of laws and decrees of the country, deepening of the healthcare reform, medical insurance directory, as well as enhancement of medical quality and patient safety. Also analyzed are such problems as development of health technology assessors, system construction, and policy transformation capability.%卫生技术评估作为当下公认的有效决策评估工具,能为医疗器械配置和管理等科学决策提供科学依据.作者通过梳理卫生技术评估在国内外发展历程,从国家法律政策、深化医改、医保目录设置和提高医疗质量、实现患者安全的层面指出医疗器械卫生技术评估的必要性,并针对当前医疗器械卫生技术评估机构建设、体系建设、政策转化能力等问题进行了分析与讨论.
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