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朝阳双井北京医疗器械三类经营许可证可全包代办专业快捷包下证

发布时间:2023-12-19        浏览次数:18        返回列表
前言:医疗器械三类,注册公司
朝阳双井北京医疗器械三类经营许可证可全包代办专业快捷包下证

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;
的企业还需要准备库房 可全程免费指导办理流程,提供质量管理员,也可托管办理,专业速度快速最快3天完成备案1、经营企业提交的《医疗器械经营企业许可证申请表》应有法定代表人签字或加盖企业公章;2、《医疗器械经营企业许可证申请表》所填写项目应填写齐全、准确;3、法定代表人的身份证明、学历职称证明、任命文件应有效;4、工商行政

suance 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 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 product requirements; (3) product inspection report; (4) clinical evaluation data; (5) product specification and label samples; (6) quality management system documents related to product development and production; enterprises need to prepare the warehouse free of charge; Provides the quality administrators, Can also be managed for handling, 1. The Application Form for Medical Device Business Enterprise License submitted by the operating enterprise shall be signed by the legal representative or affixed with the official seal of the enterprise; 2. The items filled in the Application Form for License of Medical Device Business Enterprises should be complete and acc


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