淘宝第二类医疗器械经营备案,网店二类医疗器械经营备案,电商卖医疗器械怎么办二类医疗器械经营备案呢?,淘宝店铺二类医疗器械如何备案<br><p style="border: 0px; font-style: inherit; font-weight: inherit; margin-top: 0px; margin-bottom: 0px; outline: 0px; padding: 0px; vertical-align: baseline; line-height: 2; word-break: break-all; overflow-wrap: break-word;">第二类医疗器械备案的要求:</p><p style="border: 0px; font-style: inherit; font-weight: inherit; margin-top: 0px; margin-bottom: 0px; outline: 0px; padding: 0px; vertical-align: baseline; line-height: 2; word-break: break-all; overflow-wrap: break-word;">1.要申请该备案，不可以个人名义，要以公司等其他组织形式进行申请;</p><p style="border: 0px; font-style: inherit; font-weight: inherit; margin-top: 0px; margin-bottom: 0px; outline: 0px; padding: 0px; vertical-align: baseline; line-height: 2; word-break: break-all; overflow-wrap: break-word;">2.需要提供场地租赁证明，要有房屋编码，对面积也有要求;</p><p style="border: 0px; font-style: inherit; font-weight: inherit; margin-top: 0px; margin-bottom: 0px; outline: 0px; padding: 0px; vertical-align: baseline; line-height: 2; word-break: break-all; overflow-wrap: break-word;">3.要有至少1名大专以上医药学相关的办公人员；</p><p style="border: 0px; font-style: inherit; font-weight: inherit; margin-top: 0px; margin-bottom: 0px; outline: 0px; padding: 0px; vertical-align: baseline; line-height: 2; word-break: break-all; overflow-wrap: break-word;">4.需提供所经营产品的产品证书。</p><p style="border: 0px; font-style: inherit; font-weight: inherit; margin-top: 0px; margin-bottom: 0px; outline: 0px; padding: 0px; vertical-align: baseline; line-height: 2; word-break: break-all; overflow-wrap: break-word;">办理所需资料:</p><p style="border: 0px; font-style: inherit; font-weight: inherit; margin-top: 0px; margin-bottom: 0px; outline: 0px; padding: 0px; vertical-align: baseline; line-height: 2; word-break: break-all; overflow-wrap: break-word;">1、《营业执照》(复印件);</p><p style="border: 0px; font-style: inherit; font-weight: inherit; margin-top: 0px; margin-bottom: 0px; outline: 0px; padding: 0px; vertical-align: baseline; line-height: 2; word-break: break-all; overflow-wrap: break-word;">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;</p><p style="border: 0px; font-style: inherit; font-weight: inherit; margin-top: 0px; margin-bottom: 0px; outline: 0px; padding: 0px; vertical-align: baseline; line-height: 2; word-break: break-all; overflow-wrap: break-word;">3、技术人员一览表及技术人员的身份证、学历证明、职称证书;</p><p style="border: 0px; font-style: inherit; font-weight: inherit; margin-top: 0px; margin-bottom: 0px; outline: 0px; padding: 0px; vertical-align: baseline; line-height: 2; word-break: break-all; overflow-wrap: break-word;">4、组织机构与部门设置说明;经营范围、经营方式说明;</p><p style="border: 0px; font-style: inherit; font-weight: inherit; margin-top: 0px; margin-bottom: 0px; outline: 0px; padding: 0px; vertical-align: baseline; line-height: 2; word-break: break-all; overflow-wrap: break-word;">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;</p><p style="border: 0px; font-style: inherit; font-weight: inherit; margin-top: 0px; margin-bottom: 0px; outline: 0px; padding: 0px; vertical-align: baseline; line-height: 2; word-break: break-all; overflow-wrap: break-word;">6、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;</p><p style="border: 0px; font-style: inherit; font-weight: inherit; margin-top: 0px; margin-bottom: 0px; outline: 0px; padding: 0px; vertical-align: baseline; line-height: 2; word-break: break-all; overflow-wrap: break-word;">7、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。</p>