《医疗器械经营许可证》属于后置审批

可先办理营业执照

再领取先照后证通知书

再申请办理三类医疗许可

证书有效期为5年

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；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、有创内窥镜、超声手术刀、彩色超声成像设备、激光手术设备、高频电刀、微波治疗仪、医用核磁共振成像设备、X线治疗设备、医用高能设备、人工心肺机、内固定器材、人工心脏瓣膜、人工肾、呼吸麻醉设备、一次性使用无菌注射器、一次性使用输液器、输血器、CT设备等。怎样办理许可证？01.1、一类——不用办理医疗器械许可证 第一类医疗器械是风险程度低、实行常规管理可以保证其安全有效的医疗器械，比如手术刀、手术剪、手动病床、医用冰袋、降温贴等，其产品和生产活动由所在地设区的市级食品药品监管部门实行备案管理。经营活动则全部放开，既不用许可也不用备案，只需取得工商部门核发的营业执照即可。

oval Apply business license first Then get the first license after the card notice Apply for three types of medical permission again The certificate is valid for 5 years Medical device business license 01 Medical device business license classification At present, the operation of a license, the operation of a case can be; the operation of a class of the operation of a medical device business license. Classification of the medical devices 1 Class I medical device Surgical handle and blade, ordinary hemostatic forceps, forceps, gauze stripping forceps, sponge forceps, forceps, forceps, skin forceps, instrument forceps, microear needle, microlaryngeal needle, microear hook, microlaryngeal hook, microgun, microlaryngeal forceps, forceps, microscopic needle forceps, corneal forceps, eye forceps, eye ligation forceps, gauze bandage, elastic bandage, plaster bandage, band-aid, surgical clothes, surgical cap, masks, surgical pad, surgical scarf, inspection gloves, Fsleeve, ear wash, vaginal washer, air cushion, anal pouch, Circle, urine collection bag, drainage bag, etc.; 3 three types of medical devices such as implantable cardiac pacemaker, external shock wave lithotripsy machine, patient invasive monitoring system, artificial lens, invasive endoscope, ultrasonic scalpel, color ultrasound imaging equipment, laser surgery equipment, high frequency electric knife, microwave treatment instrument, medical nuclear