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北京丰台北京医疗器械三类经营许可证提供人员库房专业快捷包下证

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、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;申请人隐瞒有关情况或者提供虚假材料的,省、自治区、
3、具有与经营产品相关的拥有中专以上学历的技术人员;
4、拥有与经营的医疗器械相适应的质量管理制度

很多药品或者医疗器械的经销商,如果没有三类医疗器械经营许可证,很多产品就不能卖,比如

pplication materials to the relevant departments; (2) the relevant departments accept the application of the applicant; (3) investigate the actual site and review the products; (4) grant the issuance of class III medical device license.2. Legal basis: Article 14 of the Regulations on the Supervision and Administration of Medical Devices for Class 1 medical devices and the application of the following data shall be submitted: (1) product risk analysis data; (2) product technical requirements; (2) product inspection report; (3) product inspection report; (4) clinical evaluation data; if the applicant conceals the relevant information or provides false materials, province, autonomous region, 3, with technical personnel with technical secondary school education or above related to the products; 4. Have the quality management system suitable to the medical devices Many distributors of drugs or medical devices cannot be sold without a license for Class III medical dev


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  • 电话:15501182773
  • 老板:马胜辉
  • 手机:15501182773
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