通州新华大街注北京医疗器械三类经营许可证提供人员库房专业快捷包下证

1、三类医疗器械经营许可证办理方式如下：
（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。
2、法律依据：《医疗器械监督管理条例》第十四条
第一类医疗器械产品备案和申请第二类、第三类医疗器械产品注册，应当提交下列资料：
（一）产品风险分析资料；
（二）产品技术要求；
（三）产品检验报告；
（四）临床评价资料；申请人以欺骗、贿赂等不正当手段取得《医疗器械经营企
（四）应当建立健全产品质量管理制度，包括采购、进货验收、仓储保管、出库复核、质量跟踪制度和不良事件的报告制度等；（五）应当具备与其经营的医疗器械产品相适应的技术培训和售后服务的能力。（六）具有与经营的医疗器械相适应的质量管理制度。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

the Regulations on the Supervision and Administration of Medical Devices for the filing of Class I medical devices and the application for the registration of Class II and Class III medical devices, The following materials shall be submitted: (1) data on product risk analysis; (2) technical requirements of the product; (3) product inspection report; and (4) clinical evaluation data; The applicant obtains the Medical Device Trading enterprise (IV) shall establish and improve the product quality management system, Including procurement, purchase acceptance, storage, warehouse review, quality tracking system and adverse event reporting system; (5) It shall have the ability of technical training and after-sales service suitable with the medical devices it operates.(6) It shall have a quality management system suitable for the medical devices in operation. Secondly, the operating enterprise should know what information it needs to prepare for the three types of medical equipment business license.(1) Submit the application form for the medical device business enterprise license, Signed by the legal representative or affixed with the official seal of the enterprise; (2) The copy of the pre-approval certificate of the enterprise name or the Business License issued by the administrative department for industry and commerce; (3) A copy of id card, educational background or professional title certificate of the person in charge of quality management of the enterprise and personal resume; Copy of the id card, educational background or professional title certificate of the quality management personnel; (4) Copy of the geographical location plan, plan (indicated area), the property right certificate or the lease agreement; (5) Enterprise product quality management system documents and catalogue of storage facilities and equipment.(6) For handling the business license of class III medical devices