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
东城东四十条北京医疗器械三类经营许可证,医疗器械二类备案提供人员库房专业快捷包下证

(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;
(五)产品说明书以及标签样稿;
二、三类医疗器械许可证注册需要什么材料10、申请材料应完整、清晰、签字,并逐份加盖公章,所有申请表格电脑打字填写,使用A4纸打印,复印使用A4纸,按照申请材料目录顺序装订成册。:申请人隐瞒有关情况或者提供虚假材料的,省、自治区、直辖市(食品)药品监督管理部门或者接受委托的设区的市级(食品)药品监督管理机构对申请不予受理或者不予核发《医疗器械经营企业许可证》,并给予警告。申请人在1年内不得再次申请《医疗器械经营企业许可证》。申请人以欺骗、贿赂等不正当手段取得《医疗器械

rvision 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) product risk analysis materials; (2) technical requirements of the product; (3) product inspection report; (4) clinical evaluation materials; (5) product specification and label samples; what materials are required for the registration of the license of Class II and III medical devices 10, the application materials shall be complete, clear and signed; And affix the official seal to each copy, All application forms are filled out by computer-based typing, Printed using A4 paper, Copying using A4 paper, Bind a book in the order of application materials.: If the applicant conceals the relevant information or provides false materials, the (food) drug regulatory department of the province, autonomous region or municipality directly under the Central Government or the (food) drug regulatory agency of the entrusted city shall not accept the application or issue the Medical Device Trading Enterprise License and give it a wa


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