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朝阳朝阳公园北京办理医疗器械三类经营许可证没有库房怎么办包过包下证快捷

更新时间:2023-11-04 00:00:00
价格:请来电询价
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
联系电话:15501182773
联系手机:15501182773
联系人:马胜辉
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详细介绍

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;

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、工商行政管理部门出具的《企业名称预先核准通知书》或《工商营业执照》的复印件应与原件相同,复印件确认留存,原件退回;

n materials to the relevant departments; (2) the relevant departments shall accept the 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 re; (3) product inspection report; (4) clinical evaluation data; (5) product description and label samples; (6) management system documents related to product development and production; 3. The identity certificate, academic title certificate and appointment documents of the legal representative shall be valid; 4. The copy of the "Notice of Pre-approval of Enterprise Name" or "Industrial and Commercial Business License" issued by the administrative department for industry and commerce shall be the same as the original, the copy shall be confirmed and retained, and the origin

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