Zhu Shumin, Xu Xiaoyuan
International and Pharmaceutical Business School of China Pharmaceutical University, Nanjing, 211198.
Zhongguo Yi Liao Qi Xie Za Zhi. 2017 Mar 30;41(2):123-126. doi: 10.3969/j.issn.1671-7104.2017.02.013.
To learn the progress, structure and the latest development of medical device postmarket surveillance system in United States, endeavor to get a meaningful approach for Chinese medical device manufacturers. Sort out the recentyear guidance documents issued by US FDA, analyze the current situation after the implementation of postmarket surveillance system (PMS). The all-aspect linkage, multiple data sources and the coordination communication mechanism between various departments implemented by FDA are worthy of learning.
了解美国医疗器械上市后监管体系的进展、架构及最新发展情况，力求为中国医疗器械制造商找到一条有意义的途径。梳理美国食品药品监督管理局（FDA）近年来发布的指导文件，分析上市后监管体系（PMS）实施后的现状。FDA实施的全方位联动、多数据来源以及各部门之间的协调沟通机制值得借鉴。
