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海淀温泉北京医疗器械三类经营许可证二三类专业快捷包拿证

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

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;

(五)产品说明书以及标签样稿;

(3)房屋产权证明、租赁协议;

(4)法定代表人、主要负责人、品质管理员的身份、毕业证等证明材料;

作为一个医疗器械资质注册咨询师,我们提供专业的医疗器械二三类资质注册服务,为您提供快捷、便宜的解决方案。如果您的公司需要在朝阳十里河地区注册医疗器械二三类资质,我们将是您的

of Class III medical devices is handled as follows: (1) The applicant shall submit the application materials to the relevant departments; (2) Relevant departments shall accept the application of the applicant; (3) Investigate the actual site and audit the products; (4) Grant the issuance of a class III medical device license. 2. Legal basis: Article 14 of the Regulations on the Supervision and Administration of Medical Devices As for the registration of Class II and III medical devices, the following materials shall be submitted: (1) Product risk analysis data; (2) Technical requirements for the products; (3) Product inspection report; (4) Clinical evaluation data; (5) Product specification and label samples; (3) Property right certificate and lease agreement; (4) Identity of legal representative, principal person in charge, quality manager, graduation certificate and other certification materials; As a medical device qualification registration consultant, we provide professional medical 

联系方式

  • 地址:北京市海淀区清河嘉园东区甲1号楼11层1124
  • 电话:15501182773
  • 老板:马胜辉
  • 手机:15501182773
  • Email:15501182773
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