丰台丰益桥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

（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；（五）产品说明书以及标签样稿；

（三）具有与经营规模和经营范围相适应的储存条件，包括具有符合医疗器械产品特性要求的储存设施、设备；

（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；

evices, the following materials shall be submitted: (1) productrisk analysis data; (2) product technical re; (3) productinspection report; (4) clinical evaluation data; (5) productdescription and label samples; (3) it shall have storage conditionscommensurate with the scale and scope of business, includingstorage facilities and e that meet the re of thecharacteristics of the medical device products; (4) the product management system shall be established and improved,including procurement, purchase and acceptance inspection, storage,warehouse delivery review, tracking system and thereporting system of adverse events; (5) it shall have the abilityof technical training and after-sales service suitable with themedical devices it operates. (6) it shall have a managementsystem suitable for the medical devices in operation. secondly, theoperating enterprise should know what information it needs toprepare for the business license of three types of medicale. (1) submit the application form for thelicense