随着互联网技术的飞速发展,移动互联、大数据和云计算等新技术和新方法在医疗器械行业得到了广泛应用,其中移动医疗器械APP软件的出现正从诊断、监护、治疗等各方面颠覆传统的医疗模式,一个智能化的医疗时代即将开启.伴随着新的医疗器械产品的出现,如何对其安全性和有效性进行有效控制,对于各国监管机构提出了新的挑战.本文在移动医疗器械APP软件定义和特征的基础上,结合美国、欧盟和中国的监管思路和方法,深入剖析软件更新这一监管难点,提出了移动医疗器械APP软件的监管建议以及面临的挑战,旨在为监管工作提供支持和帮助.%With the rapid development of internet technology, new technologies and new methods, such as internet technology, mobile internet, big data and cloud computing and so on, are rapidly developed and widely applied in medical equipment industry. The emergence of mobile medical devices APP software is making revolutionary changes to the traditional healthcare from the aspects of diagnosis, monitoring, and treatment. An intelligent medical era is approaching. Along with the emergence of new medical products, how to effectively control its safety and effectiveness raised new challenges to regulatory agencies. Based on the definition and features of mobile medical APP software, this paper combined the regulation ideas and methods of the United States, the European Union and China, and performed an in-depth analysis on the challenge of software update regulation, and proposed regulatory advice and faced the challenge for the mobile medical APP software, expected to provide support and help for the regulation work.
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