朝阳百子湾北京医疗器械三类经营许可证,医疗器械二类备案提供进销存软件人员专业快捷包下证
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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;3三类医疗器械二类——市药监局办理医疗器械经营备案 第二类医疗器械是具有中度风险,需要严格控制管理以保证其安全有效的医疗器械,比如我们日常生活中常见的创可贴、避孕套、体温计、血压计、制氧机、雾化器等,其产品和生产活动由省级食品药品监管部门实行许可管理,分别发给《医疗器械注册证》和《医疗器械生产许可证》。经营活动由设区的市级食品药品监管部门实行备案管理;三类——国家药监局办理医疗器械许可证 第三类医疗器械是具有较高风险,需要采取特别措施严格控制管理以保证其安全有效的医疗器械,比如常见的输液器、
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 Class III medical devices Class II —— Municipal Food and Drug Administration for medical device business record Class II medical devices have moderate risk, Need for strict control and management to ensure their safe and effective medical devices, For e