医疗器械行业现状CAO Changzai(曹常在),WU Hongbin(武宏斌),ZHANG Mingyan(张明艳),SUN Li(孙莉),Li Yongzheng(黎永正)天津市塑料研究所有限公司 摘要:通过概述医疗器械,进而深入了解其市场法规,论述目前国内外医疗器械的发展现状及影响因素,同时对其进行不同的具体分类,并介绍目前国内外主要生产商基本情况,展望了未来医疗器械的发展前景关键词:医疗器械;市场法规;发展前景;医疗耗材Abstract: Overview of medical devices, and then understanding of the regulations of market, discusses the current domestic and international situation and affect factors of medical devices, the different specific classification, and introduced the basic situation of the major manufacturers at home and abroad, looked to the future for the development of medical devices
Keywords: medical device; market regulation; development prospect; medical supply1.综述医疗器械,是指单独或者组合使用于人体的仪器、设备、器具、材料或者其他物品,包括所需要的软件;其用于人体体表及体内的作用不是用药理学、免疫学或者代谢的手段获得,但是可能有这些手段参与并起一定的辅助作用;其使用旨在达到下列预期目的:(一)对疾病的预防、诊断、