海淀苏州桥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

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北京星期三企业管理咨询有限公司业务部  
医疗器械三类
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医疗器械二类
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网络销售备案
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联系人
马胜辉(先生)
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15501182773
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15501182773
发布日期
2023-12-18 11:36
编号
12961354
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

三类医疗器械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;
(六)与产品研制、生产有关的质量管理体系文件;
(七)证明产品安全、有效所需的其他资料。4、工商行政管理部门出具的《企办理三类医疗器械经营许可证的办理流程:
1.向食品药品监督管理局提交医疗器械经营许可证申请材料;
2.食品药品监督

How to handle the business license of Class III medical device 1. The business license of Class III medical devices is as follows: (1) the applicant submits the application materials to the relevant departments; (2) the relevant department accepts the application of the applicant; (3) investigate the actual site and review the product; (4) grant the issuance of the Class III medical device license.2. Legal basis: Article 14 of 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, the following materials shall be submitted: (1) product risk analysis data; (2) technical requirements of the product; (3) product inspection report; (4) clinical evaluation data; (5) product instructions and label samples; (6) quality management system documents related to product development and production; (7) other materials required to prove the safety and effectiveness of the product.4. Procedures for handling the business license of Class III medical devices issued by the administrative department for industry and commerce: 1. Submit the application materials for the medical device business license to the Food and Drug Administration; 2. Food and d



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