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海淀西二旗没有人员怎么办北京医疗器械三类经营许可证提供人员库房专业安全包下证

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)临床评价资料;
(五)产品说明书以及标签样稿;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

dical Devices For filing of Class I medical devices and application for registration of Class II and III medical devices, the following materials shall be submitted: (1) product risk analysis data; (2) product technical requirements; (3) product inspection report; (4) clinical evaluation data; (5) product instruction manual and label samples; 10. The application materials shall be complete, clear and signed, stamped with official seal, one by one, and all application forms shall be typed by computer, printed on A4 paper, copied with A4 paper, and bound in order with the list 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 level (food) drug regulatory agency of the entrusted city divided into districts shall not accept or approve the application


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