seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">对于第二类医疗器械经营备案人员有要求：
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seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">1、法人兼任企业负责人的需要有大专以上学历，不做要求；
seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">
seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">2、质量负责人需要有3年以上工作经验，大专以上学历，相关毕业；
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seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">医疗器械相关指：医疗器械、生物医学工程、机械、电子、医学、生物工程、化学、护理学、康复、检验学、管理、计算机等
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seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">三、对于第二类医疗器械经营备案材料有要求：
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seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">1、第二类医疗器械经营备案申请表
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seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">2、营业执照和组织机构代码证复印件；
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seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">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；
seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">
seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">4、组织机构与部门设置说明；
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seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">5、经营范围、经营方式说明
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seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">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租赁协议（附房屋产权证明文件）复印件；
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seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">7、经营设施、设备目录；
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seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">8、经营质量管理制度、工作程序等文件目录；
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seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">9、经办人授权证明；