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海淀万泉河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:17        返回列表
前言:注册公司,医疗器械三类
海淀万泉河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

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;4、工商行政管理部门出具的《企业名称预先核准通知书》申请人以欺骗、贿赂等不正当手段取得《医疗器械经营企业许可证》的,(食品)药品监督管理部门

w to handle the business license of Class III medical device 1. The business license of Class III medical device is as follows: (1) the applicant submits the application materials to the relevant department; (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 the Supervision and Administration of Medical Devices and the registration of medical devices and the third category, the following data shall be submitted: (1) the product risk analysis data; (2) the application of the product technical requirements; (3) the product inspection report; (4) the clinical evaluation data of the products and the application of the administrative department, and (food) the drug supervision and administration department


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