《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;
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
finger cover, ear ball, vaginal washer, air cushion, anal bag, ring, collection of urine bag, drainage bag, etc.; 2 Class II medical devices Such as thermometer, blood pressure monitor, help aid, oxygen generator, condom, acupuncture needle, electrocardiac diagnostic instrument, non-invasive monitoring instrument, optical endoscope, portable ultrasound diagnostic instrument, automatic biochemical analyzer, constant temperature incubator, teeth