其次,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;
(4)准予颁发三类医疗器械许可证。
二、第三类医疗器械经营许可证办理流程:
1、经营企业经办人携带上述资料前往监督管理部门申请经营许可;
2、工作人员受理资料,并于30个工作日内进行审查,必要时组织核查;
the administrative department for industry and commerce; (3) Acopy of the id card, educational background or professional titlecertificate and personal resume of the management managerof the enterprise; a copy of the ID card, educational background orprofessional title certificate of the management personnel;(4) The map of the geographical location, the plan (indicating thearea), the property right certificate or the copy of the leaseagreement; (5) Enterprise product management systemdocuments and catalogue of storage facilities and e (6)Table of transportation e and storage facilities ande available by the enterprise when the contents of thebusiness license contains drugs that need to be refrigerated. , Thethird type of medical e business license how to handle (1)The applicant shall submi