通过探讨《组合产品上市前路径指导原则》的相关要求,分析美国食品药品管理局(Food and Drug Administration,FDA)对含药医疗器械5种典型情况的申报路径、参比器械选择的审评关注点,以期对我国以医疗器械作用为主的药械组合产品的申报...通过探讨《组合产品上市前路径指导原则》的相关要求,分析美国食品药品管理局(Food and Drug Administration,FDA)对含药医疗器械5种典型情况的申报路径、参比器械选择的审评关注点,以期对我国以医疗器械作用为主的药械组合产品的申报注册提供参考借鉴。展开更多
The paper summarizes the research on the development of standards for tunnels and roads LED lighiing application in Shanghai. analyzes the existing problems on LED road lamps and lighting design, introduces the experi...The paper summarizes the research on the development of standards for tunnels and roads LED lighiing application in Shanghai. analyzes the existing problems on LED road lamps and lighting design, introduces the experiments and testing results, and summarizes current problems of LED street lighting, proposing that LED lighting energy conservation should he "systematic energy saving" throughout the full life cycle based on the integration of products and applications.展开更多
文摘The paper summarizes the research on the development of standards for tunnels and roads LED lighiing application in Shanghai. analyzes the existing problems on LED road lamps and lighting design, introduces the experiments and testing results, and summarizes current problems of LED street lighting, proposing that LED lighting energy conservation should he "systematic energy saving" throughout the full life cycle based on the integration of products and applications.