为强化医疗器械生产企业的日常监管和有源医疗器械专项督查,10月下旬,湖南省食药监局依据《药品医疗器械飞行检查办法》,从全省随机抽取8名检查员对12家医疗器械生产企业进行了飞行检查。检查发现,部分企业能按照《医疗器械生产质量管理规范》的要求建立质量管理体 In order to strengthen the routine supervision of medical device manufacturers and the special supervision of active medical devices, in late October, Hunan Food and Drug Administration decided to randomly select 8 inspectors from 12 provinces based on the Measures for the Inspection of Medicines and Medical Devices Flight Medical device manufacturers conducted a flight check. Inspection found that some companies in accordance with the “medical device manufacturing quality management practices,” the requirements of the establishment of quality management body