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关于我国医疗器械生产环节开展数字化监管的思考

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近年来,我国医疗器械产业高速发展,数字化转型成为推动产业高质量发展的重要手段,产业数字化水平不断提升.产业数字化的快速发展推动了监管数字化的发展,为提升监管效能提供了新思路.目前,我国已有多个地区开展了智慧监管试点工作,并取得初步成效.与此同时,产业数字化面临企业数字化转型成本高,不同规模企业的数字化转型进程差距大,产业数字化推进难等问题;监管数字化面临缺乏有效规划和统一设计,系统、平台重复建设,协同监管效能低等问题.本文围绕医疗器械生产环节数字化转型和监管数字化,探索了生产企业和监管部门的数字化转型技术方案并提出建议,以期为推动医疗器械生产环节数字化、监管数字化转型提供思路.
Thoughts on the Digital Supervision of the Manufacturing Stage of Medical Devices in China
In recent years,China's medical device industry has been developing rapidly,with digital transformation emerging as an important means to promote high-quality development.The level of digitalization in the industry has steadily improved,and the swift progress of industrial digitalization has accelerated the development of digital supervision,offering new approaches to enhance supervisory efficiency.Several regions in China have initiated pilot programs for intelligent supervision,yielding initial positive results.However,challenges remain for industrial digitalization:enterprises face high costs for digital transformation,significant disparities exist in the digital transformation processes of enterprises of different scales,and there are difficulties in promoting industrial digitalization.Similarly,in terms of digital supervision,there is a lack of effective planning and unified design,widespread redundancy in platform construction,and low efficiency in collaborative supervision.This article focuses on the digital transformation of the medical device manufacturing stage and digital supervision,explores technical solutions for the digital transformation of both enterprises and regulatory authorities.It also puts forward suggestions for promoting the continuous improvement of digital intelligence in medical device manufacturing stage and the level of digital supervision.

medical devicesmanufacturing stagenovel information technologydigital transformationdigital supervision

林家颐、李丹荣

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国家药品监督管理局南方医药经济研究所

医疗器械 生产环节 新型信息技术 数字化转型 数字化监管

2024

中国食品药品监管
中国医药报社

中国食品药品监管

影响因子:0.099
ISSN:1673-5390
年,卷(期):2024.(9)
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