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；
3、对符合规定条件的，准予许可并发给医疗器械经营许可证；对不符合规定条件的，不予许可并书面说明理由。
cational background or professional title certificate of thequality management personnel; (4) The business site, the warehouseof the geographical location map, the plan (indicating the area),the property right certificate or the 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 equipmentprovided by the enterprise when the business license contains drugsthat need to be refrigerated. , The third type of medical equipmentbusiness license how to handle (1) The applicant shall submit theapplication materials to the relevant departments; (2) Relevantdepartments shall accept the application of the applicant; (3)Investigate the actual site and audit the products; (4) Grant theissuance of a class III medical device license. 2. Process forhandling the business license of Class III Medical Devices: 1. Theoperator of the operating enterprise shall apply to the supervisionand administration department for the business license with theabove information; 2. The staff shall accept the materials andreview them within 30 working days, and organize verification ifnecessary; 3.
