创新发展视角下我国医疗器械分类界定电子化研究

Study on Medical Device E-classification in China from Perspective of Innovation and Development

医疗器械创新发展已势不可挡,越来越多的创新产品亟待在上市前进行分类界定。医疗器械分类不仅是医疗器械监管的基础,也是影响产业创新发展的重要因素。针对目前分类界定耗时较长等现状,该研究根据我国医疗器械监管法规,依托数字化、网络化、智能化技术发展,以放射治疗设备分类界定为例,重点探讨分类界定电子化框架下依据、方式、维度、技术路线等,探索提高分类界定效能,促进医疗器械创新发展。

With the overwhelmingly booming trend of innovation in medical devices,more and more innovative products are in urgent need of classification before marketing.Medical device classification is not only a basis of regulation but also a key factor affecting industry innovation and development.In view of the current situation of classification process in China has been time-consuming,this study discusses an E-classification framework including its classification basis,method,dimensions and technical roadmap,etc.based on medical devices regulations in China illustrated by the classification of radio therapeutic equipment,taking advantage of digitalization,networking and intelligence,and explores the improvement of classification efficiency to promote the innovation and development of medical devices.