代办朝阳区三类医疗器械经营许可证，二类医疗器械经营备案凭证

申请二类医疗器械经营备案凭证所需要的申请材料：

       1. 第二类医疗器械经营备案表

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　　2.营业执照和组织机构代码证复印件

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　　3.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

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　　4.组织机构与部门设置说明

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　　5.经营范围、经营方式说明;

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　　6.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租赁凭证复印件;

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　　7.经营设施、设备目录;

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　　8.经营质量管理制度、工作程序等文件目录;

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　　9.经办人授权证明。

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　　注意事项：在递交书面申报材料前，应通过食品药品监督管理局网上提交行政许可预审申请，预审通过的，企业在提交纸质申请材料时须提交该预受理号。申请材料请逐页盖章或经由法定代表人或企业负责人签字;材料请用拉杆夹装订整齐。

　　申领《医疗器械经营许可证》时需提交的材料：

      1.《医疗器械经营许可证申请表》(原件1份);

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　　2.《营业执照》(复印件);

　　3.组织机构代码证(复印件);

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　　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);

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　　5.质量管理人员的工作简历(原件1份);

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　　6.技术人员一览表(原件1份)及*技术人员的身份证、学历证明、职称证书(复印件各1份);

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　　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，)。

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　　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);

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　　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)。

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　　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)。

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　　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)。

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　　根据企业销售的产品不同，需要办理不同的资质，具体如何分类的可要查看我们之前发布的医疗器械分类或者直接向我们的客服进行详细咨询。

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