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海淀万寿路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

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;

(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**选择。

医疗器械二三类属于国家食品药品监督管理局规定的医疗器械管理规范中的一种分类,是一种较为常见的医疗器械分类。如果您有相关产品需要上市,就需要完成医疗器械二三类资质注册。

我们的服务快速、便宜且专业。我们非常了解企业在医疗器械资质注册过程中的需求和苦处。因此,我们始终致力于为企业提供优质的服务,以*快速的时间、*优质的服务

 to handle the business license of class III medical devices 1. The business license 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 device Class II and Class III qualification registration service, to provide you with quick and cheap solutions. If your company needs to register the qualification in Shilihe, Chaoyang, we will be your best choice. Class II and Class III of medical devices is one of the medical device management norms stipulated by the State Food and Drug Administration, which is a relatively common classification of medical devices. If you have related products to be marketed, you need to complete the registration of class II medical device qualification. Our service is fast, cheap, and very professional. We are well aware of the needs and hardships of enterprises in the medical device qualification registration process. Therefore, we are always committed to providing quality service for enterprises, with the fastest time, the best quality service

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  • 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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