seline; hyphens: auto; overflow-wrap: break-word; text-align: justify; color: rgb(51, 51, 51); white-space: normal; background-color: rgb(255, 255, 255);">二类医疗器械网上备案流程:
seline; hyphens: auto; overflow-wrap: break-word; text-align: justify; color: rgb(51, 51, 51); white-space: normal; background-color: rgb(255, 255, 255);">一、申请第二类医疗器械经营备案应提交的资料:
seline; hyphens: auto; overflow-wrap: break-word; text-align: justify; color: rgb(51, 51, 51); white-space: normal; background-color: rgb(255, 255, 255);">1、营业执照;
seline; hyphens: auto; overflow-wrap: break-word; text-align: justify; color: rgb(51, 51, 51); white-space: normal; background-color: rgb(255, 255, 255);">2、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;
seline; hyphens: auto; overflow-wrap: break-word; text-align: justify; color: rgb(51, 51, 51); white-space: normal; background-color: rgb(255, 255, 255);">3、组织机构与部门设置说明;
seline; hyphens: auto; overflow-wrap: break-word; text-align: justify; color: rgb(51, 51, 51); white-space: normal; background-color: rgb(255, 255, 255);">4、经营范围、经营方式说明;
seline; hyphens: auto; overflow-wrap: break-word; text-align: justify; color: rgb(51, 51, 51); white-space: normal; background-color: rgb(255, 255, 255);">5、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)
seline; hyphens: auto; overflow-wrap: break-word; text-align: justify; color: rgb(51, 51, 51); white-space: normal; background-color: rgb(255, 255, 255);">6、经营设施、设备目录;
seline; hyphens: auto; overflow-wrap: break-word; text-align: justify; color: rgb(51, 51, 51); white-space: normal; background-color: rgb(255, 255, 255);">7、经营质量管理制度、工作程序等文件目录;
seline; hyphens: auto; overflow-wrap: break-word; text-align: justify; color: rgb(51, 51, 51); white-space: normal; background-color: rgb(255, 255, 255);">8、鼓励使用计算机信息管理系统;
seline; hyphens: auto; overflow-wrap: break-word; text-align: justify; color: rgb(51, 51, 51); white-space: normal; background-color: rgb(255, 255, 255);">9、经办人授权证明;
seline; hyphens: auto; overflow-wrap: break-word; text-align: justify; color: rgb(51, 51, 51); white-space: normal; background-color: rgb(255, 255, 255);">10、签字并加盖公章的申请表扫描版;
seline; hyphens: auto; overflow-wrap: break-word; text-align: justify; color: rgb(51, 51, 51); white-space: normal; background-color: rgb(255, 255, 255);">11、其他证明材料。