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2014年7月15日,美国食品药品监督管理局(简称FDA)驻华办公室一行到北京市医疗器械检验所进行工作访问,北京市食品药品监管局党组成员、副局长卢爱丽陪同。访问期间,美国FDA驻华办代表一行不仅参观了北京市医疗器械检验所血细胞分析参考实验室、机电检测实验室、电磁兼容检测等专业实验室,双方还进行了座谈交流。座谈会上,北京市医疗器械检验所主要负责人向来访嘉宾介绍了检验所的基本情况、检验检测能力建设、标准科研工作以及与国际间合作及学术交流等情况。美国FDA驻华办代表也向与会人员介绍了美国FDA关于进口医疗器械产品检验流程规定及风险监测信息化手段。双方还就中美医疗器械检验检测体系设置、进口医疗器械产品检测与法规政策要求、医疗器械产品风险监测以及今后的合作交流等问题进行了交流。
On July 15, 2014, the U.S. Food and Drug Administration (FDA) office in China conducted a working visit to the Beijing Medical Device Inspection Institute and was accompanied by Lou Aili, member of the party committee and deputy director of Beijing Food and Drug Administration. During the visit, the representative delegation from FDA to China not only visited professional laboratories such as the Reference Laboratory for Blood Cell Analysis, the Mechanical and Electrical Testing Laboratory, and the Electromagnetic Compatibility Test in the Beijing Medical Device Testing Institute, but also conducted discussions and exchanges. At the symposium, the chief person in charge of Beijing Medical Device Inspection Institute briefed visiting guests on the basic conditions of the laboratory, the capacity of testing and testing, the standard of scientific research, cooperation with other countries and academic exchanges. Representatives from the FDA to China also briefed the participants on the FDA’s procedures for the inspection of imported medical device products and the means of risk monitoring information. The two sides also exchanged views on the establishment of the testing and testing system for medical devices in China and the United States, the inspection of import medical device products, the requirements of laws and regulations, the risk monitoring of medical device products, and future cooperation and exchanges.