北京星期三企业管理咨询有限公司业务部
工商注册 , 资质审批 , 代理记账 , 建委资质 , 舞美资质 , 拍卖资质
海淀万寿寺北京医疗器械三类经营许可证二三类专业快捷包拿证

、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。

首先,要根据规定明确产品的分类,选择符合规范的产品名称和用途。然后,需要获取医疗器械二三类产品的技术评估报告和公告批件,提供相关资料完成注册申请并进行后续审批程序。在整个流程中,我们会提供全程咨询服务,协助您完成所有相关工作。

 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. First of all, the classification of products should be clear according to the regulations, and the product name and use that meet the specification. Then, it is necessary to obtain the technical evaluation report and announcement approval of medical devices, provide relevant materials to complete the registration application and conduct follow-up approval procedures. In the whole process, we will provide full consulting services to assist you with all the related work.

展开全文
相关产品
拨打电话 发送询价