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朝阳三元桥北京办理医疗器械三类经营许可证没有库房怎么办包过包下证快捷

(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;医疗器械二类备案流程: 1、准备执照副本,

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》。

the Regulations on Supervision and Administration of Medical Devices for the filing of Class I medical devices and the application for the registration of Class II and III medical devices shall submit the following materials: (1) product risk analysis data; (2) product technical re; (3) product inspection report; (4) clinical evaluation data; (5) product description and label samples; the filing process of Class II medical devices: 1. Prepare a copy of the license, 10. The application materials should be complete, clear and signed, and stamped with official seal. All application forms should be filled in by computer typing, printed on A4 paper, copied on A4 paper, and bound in the order of application materials. Where 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 warning. The applicant shall not apply for the Medical Device Business Enterprise License again within one year.

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