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      当前位置:首页 > 进出口许可证申请 > 医疗器械经营许可证怎么办理

      医疗器械经营许可证怎么办理

      • 作者:深圳公司注册
      • 时间:2019-01-26 16:14:08

      很多经营医疗器械的人对自己经营的东西要办理什么并不是很清楚,认为只要经营医疗器械的就需要办理医疗器械经营许可证。这种想法,其实是不正确的。今天,小编就来和大家说说怎么根据自己经营的医疗器械来判断自己要不要办理经营许可证。
       
      一、医疗器械经营许可证分类:
       
      1.一类:通过常规管理足以保证其安全性、有效性的医疗器械;
       
      2.二类:对其安全性、有效性应当加以控制的医疗器械;
       
      3.三类:植入人体;用于支持、维持生命;对人体具有潜在危险,对其安全性、有效性必须严格控制的医疗器械。
       
      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。
       
      二、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。
       
      详细的分类大家可以在网上查到。
       

       
      三、二类申请备案所需材料:
       
      1.第二类医疗器械经营备案表;
       
      2.企业营业执照和组织机构代码证复印件;
       
      3.企业法定代表人或负责人身份学历证明;
       
      4.企业组织机构与部门设置说明;
       
      5.经营范围、方式说明;
       
      6.经营场所、库房地址租赁凭证、房屋产权证明文件;
       
      7.经营场所、库房地址的设施、设备目录;
       
      8.经办人授权证明;
       
      9.申请材料真实性的承诺材料,法人签字盖章;
       
      10.其他证明材料。
       
      四、三类申请医疗器械经营许可证条件:
       
      1.具有与经营规模和经营范围相适应的质量管理机构或者专职质量管理人员。质量管理人员应当具有国家认可的相关专业学历或者职称;
       
      2.具有与经营规模和经营范围相适应的相对独立的经营场所;
       
      3.具有与经营规模和经营范围相适应的储存条件,包括具有符合医疗器械产品特性要求的储存设施、设备;
       
      4.应当建立健全产品质量管理制度,包括采购、进货验收、仓储保管、出库复核、质量跟踪和不良事件的报告制度等;
       
      5.应当具有与其经营的医疗器械产品相适应的技术培训和售后服务的能力,或者约定由第三方提供技术支持;
       
      6.经营无菌和植入类产品的公司需建立计算机管理系统及计算机管理制度,能够保证产品从购进到销售整个过程的有效质量跟踪和追溯。
       
      五、申请医疗器械经营许可证所需材料:
       
      1.《医疗器械经营许可证申请表(原件1份);
       
      2.《营业执照(复印件);
       
      3.组织机构代码证(复印件);
       
      4.法定代表人、企业负责人、质量负责人的身份证明、学历或者职称证明(复印件1
      份);
       
      5.质量管理人员的工作简历(原件1份);
       
      6.专业技术人员一览表(原件1份)及专业技术人员的身份证、学历证明、职称证书(复印件各1份);
       
      7.组织机构与部门设置说明;
       
      8.经营范围、经营方式说明;
       
      9.经营场所、库房地址的地理位置图、平面图、房屋产权证明文件或者由房屋租赁所出具的房屋租赁凭证复印件。属仓储委托医疗器械第三方物流的,提供委托合同(复印件1份);
       
      10.经营设施、设备目录;
       
      11.经营质量管理制度、工作程序等文件目录. 包括采购、验收、入库、出库、质量跟踪、用户反馈、不良事件监测和质量事故报告制度等文件(原件1份);
       
      12.办理医疗器械经营许可证企业已安装的计算机信息管理系统基本情况介绍和功能说明 ,打印信息管理系统首页(原件1份);
       
      13.凡申请企业申报材料时,办理人员不是法定代表人或企业负责人本人,企业应当提交《授权委托书(原件1份);
       
      14.申报材料真实性的自我保证声明,包括申请材料目录和企业对材料作出如有虚假承担法律责任的承诺(原件1份)。
       
      看完了以上的内容,大家是不是对自己经营的东西要办理什么,有了一定的了解呢,如果您还有什么疑惑,欢迎来咨询。


      深圳公司注册


      深圳工商注销


      深圳市潮鼎盛企业管理有限公司是一家经深圳市财政局批准、深圳市工商行政管理局注册登记,依法独立代办公司注册、财税咨询、代理记帐等业务的社会中介服务机构,公司专注于深圳工商财税服务10年,熟悉注册公司流程,服务3000多家企业,欢迎咨询潮鼎盛财税。

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