医疗器械经营许可证
01医疗器械经营许可证分类
目前,经营一类的是不需要办理许可证的,经营二类的备个案就可以了;经营三类的需要办理三类的医疗器械经营许可证。
医疗器械的分类
1一类医疗器械
手术刀柄和刀片、普通止血钳、子弹钳、纱布剥离钳、海绵钳、帕巾钳、皮管钳、器械钳、显微耳针、显微喉针、显微耳钩、显微喉钩、显微枪形麦粒钳、显微喉钳、显微持针钳、角膜镊、眼用镊、眼用结扎镊、纱布绷带、弹力绷带、石膏绷带、创口贴、手术衣、手术帽、口罩、手术垫单、手术洞巾、检查手套,指套、洗耳球、阴道洗涤器、气垫、肛门袋,圈、集尿袋、引流袋等;
2二类医疗器械
如体温计、血压计、助昕器、制氧机、避孕套、针灸针、心电诊断仪器、无创监护仪器、光学内窥镜、便携式超声诊断仪、全自动生化分析仪、恒温培养箱、牙科综合治疗仪、医用脱脂棉、医用脱脂纱布等;
3三类医疗器械
如植入式心脏起搏器、体外震波碎石机、病人有创监护系统、人工晶体、有创内
device business license classification At present, the operation of a class is not a license, the operation of a case can be; the operation of a class of the medical device business license. Classification of the medical devices 1 Class I medical device Surgical handle and blade, ordinary hemostatic forceps, bullet clamp, gauze stripping forceps, sponge forceps, pads, forceps, instrument forceps, forceps, forceps, microear needle, microlaryngeal needle, microear hook, microlaryngeal hook, forceps, microlaryngeal forceps, forceps, microneedle forceps, corneal forceps, eye forceps, forceps, gauze bandage, elastic bandage, plaster bandage, band-aid, surgical clothing, surgical cap, surgical cap, mask, surgical pad,