北京星期三企业管理咨询有限公司业务部
工商注册 , 资质审批 , 代理记账 , 建委资质 , 舞美资质 , 拍卖资质
大兴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

(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;l 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) risk analysis data of the product; (2) technical requirements of the product; (3) product inspection report; (4) clinical evaluation data; if the applicant conceals relevant information or provides false materials, province, autonomous region and (3) It shall have storage conditions commensurate with the scale and scope of business, including storage facilities and equipment that meet the requirements of the characteristics of the med

申请人隐瞒有关情况或者提供虚假材料的,省、自治区、

(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


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