海淀上庄北京医疗器械三类经营许可证可全包代办专业快捷包下证

三类医疗器械经营许可证如何办理
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）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

ials to the relevant department; (2) the relevant department accepts the application of the applicant; (3) investigate the actual site and review the product; (4) grant the issuance of the Class III medical device license.2. Legal basis: article 14 of the Regulations on supervision and Administration of Medical Devices for filing and applying for the registration of category II and category III medical devices, the following materials shall be submitted: (1) product risk analysis data; (2) product technical requirements; (3) product inspection report; (4) The product quality management system shall be established and improved, including procurement, purchase and acceptance inspection, storage, warehouse delivery review, quality tracking system and the reporting system of adverse events; (5) It shall have the ability of technical training and after-sales service suitable with the medical devices it operates. (6) having and oper