房山琉璃河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
2023-12-17 10:46
编号
12924579
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、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;
二、三类医疗器械许可证注册需要什么材料
三类医疗器械许可证注册所需材料如下:
1、企业名称与经营范围,注册资本及股东出资比例,股东等身份证明;
2、医疗器械产品注册证书、供

ws: (1) the applicant submits the application materials to the relevant departments; (2) the relevant departments accept the application of the applicant; (3) investigate the actual site and review the products; (4) grant the issuance of the Class 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 the application for the registration of Class II and Class III medical devices, The following materials shall be submitted: (1) product risk analysis data; (2) technical requirements for product; (3) product inspection report; (4) clinical evaluation data; (5) product specification and label samples; what materials are required for license registration of Class II and III medical devices The materials required for license registration of Class III medical devices are as follows: 1. Enterprise name and business scope, The proportion of the registered capital and the shareholders' capital contribution, Identification certificate of shareholders; 2. Registration certificat



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