朝阳常营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

供货厂家
北京星期三企业管理咨询有限公司业务部  
医疗器械三类
注册
医疗器械二类
注册
注册公司
网络销售备案
报价
电议
联系人
马胜辉(先生)
手机
15501182773
询价邮件
15501182773
发布日期
2023-12-18 08:21
编号
12953034
发布IP
114.246.180.135
区域
北京公司注册
地址
北京市海淀区清河嘉园东区甲1号楼11层1124
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详细介绍

(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;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

rtments; (2) the relevant departments shall accept the application of the applicant's application; (3) investigate the actual site and review the products; (4) grant the issuance of the third III medical device license.2. Legal basis: Article 14 of the Regulations on the Supervision and Administration of Medical Devices for the filing of Class I medical devices and application for the registration of Class II and Class 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; 10. The application materials shall be complete, clear, signed, stamped with official seal, all application forms shall be filled in by computer, printed on A4 paper, copied on 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) and drug regulatory department of the province, autonomo



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