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朝阳柳芳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 06:36  点击:12次

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;
6.有关部门的行政决定;
7.制证、发证。
办理三类医疗器械经营许可证的条件如下:
1、具有

partments 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 Supervision and Administration of Medical Devices For filing of Class I medical devices and application for 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; 6. administrative decisions of relevant departments; 7. certificate preparation and certification. The conditions for applying for the business license of Class II


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