二、办理医疗器械三类经营许可证需要的资料：
(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。
1. What is a medical device? Beijing wants tounderstand the enterprises to see here Medical device: refers toinstruments, equipment, appliances, materials or other articlesused individually or in combination, including required software;their function on the surface of the body is not obtained bypharmacological, immunology or metabolic means, but may participateand play a certain auxiliary role. 2. How many categories aremedical devices divided into? There are three categories: Theoperation of the first type of medical devicesdoes
