经营企业要知晓办理三类医疗器械经营许可证需要准备哪些资料。
(1)提交医疗器械经营企业许可证申请表,法定代表人签字或加盖企业公章;
(2)工商行政管理部门出具的企业名称预核准证明文件或《营业执照》复印件和校验原件;
(3)企业质量管理负责人的身份证、学历或者职称证明复印件及个人简历;质量管理人员的身份证、学历或者职称证明复印件;
(4)经营场所、仓库的地理位置图、平面图(注明面积)、房屋产权证明或者租赁协议复印件;
(5)企业产品质量管理制度文件及储存设施、设备目录。
(6)对于办理三类医疗器械经营许可证内容包含有需要冷藏的药品时,企业具备的运输装备、仓储设施设备情况表。
、第三类医疗器械经营许可证怎么办理
(1)申请人提交申请资料到相关部门;
(2)相关部门受理申请人的申请;
(3)到实际场地进行勘察以及对产品进行审核;
ical device trading enterprise, signed by the legalrepresentative or affix the official seal of the enterprise; (2) Acopy of the pre-approval certificate of the enterprise name or theBusiness License issued by the administrative department forindustry and commerce; (3) a copy of the id card, educationalbackground or professional title certificate and personal resume ofthe quality management manager of the enterprise; a copy of the IDcard, educational background or professional title certificate ofthe quality management personnel; (4) The business site, warehouseof the geographical location plan, plan (indicating the area), theproperty right certificate or lease copy of the agreement; (5)Enterprise product quality management system documents andcatalogue of storage facilities and equipment. (6) Table oftransportation equipment and storage facilities and equipmentavailable by the enterprise when the contents of the busin