摘要
移动医疗器械的监管是当前业内关注的热点之一。结合移动计算技术和美国FDA移动医疗应用指南,分析讨论了移动医疗器械的定义、监管范围与要求、潜在风险。我国移动医疗器械的监管工作需要采用基于风险的方法。
The regulation of mobile medical devices is one of the hot topics in the industry now. The definition, regulation scope and requirements, potential risks of mobile medical devices were analyzed and discussed based on mobile computing techniques and the FDA guidance of mobile medical applications. The regulation work of mobile medical devices in China needs to adopt the risk-based method.
出处
《中国医疗器械杂志》
CAS
2015年第4期272-274,共3页
Chinese Journal of Medical Instrumentation
关键词
移动医疗器械
移动医疗应用
监管
风险
mobile medical device, mobile medical application, regulation, risk
