美国FDA医疗器械智慧监管现状与启示

The Current Situation of US FDA′s Smart Supervision of Medical Devices and Its Implication

新技术、新材料、新工艺的井喷式涌现使得医疗器械产业呈现多元创新的发展态势,传统的监管方式难以适应医疗器械产业快速发展的需要,世界各国都在积极探索信息化监管方式。我国也要与时俱进,利用现代科技手段推动监管创新,打造医疗器械监管信息化平台,推动实现“互联网+监管”的智慧监管模式,提高我国医疗器械监管效能。为此,本研究对美国食品药品管理局信息化战略规划及医疗器械智慧监管情况进行了梳理,并结合我国药监部门智慧监管体系的发展现状,提出提升策略,包括优化顶层设计、共建共享共治、深挖数据价值,期望对我国医疗器械智慧监管体系建设起到启示作用。

The rapid emergence of new technologies,new materials,and new processes has led to a diversified and innovative development trend of medical device industry.Traditional supervisory approaches are unable to keep up with the rapid development of the medical device industry,and countries around the world are actively exploring informatization supervision mode.China should also keep pace with the times,use modern technology to promote supervisory innovation,create the information platform for medical device supervision,and promote the smart supervisory model of“Internet+supervision”to improve the efficiency of medical device supervision.Therefore,this study reviewed the information technology strategic plans and smart supervisory situation of the US Food and Drug Administration(FDA),combined with the development status of smart supervision sytem of China′s drug regulatory departments,and proposed improvement strategies,including optimizing top-level design,co-building,sharing and co-governance,and exploring the value of data,so as to provide inspiration for the construction of China′s medical device smart supervision system.