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
海淀大钟寺北京医疗器械三类经营许可证二三类专业快捷包拿证

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;

(5)经营地平面设计图,仓库平面设计图。

三类医疗器械许可证怎么样办

 

充分考虑医药行业相关法律法规及管控规定许多 ,跨专业工作人员没办法申请办理取得成功或产生后遗症,

提议找医疗器械专业第三方服务项目组织申请办理。由

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; (5) Operation floor plan design drawing, warehouse floor plan design drawing. How to do the third-class medical device license Fully considering the relevant laws and regulations and control provisions of the pharmaceutical industry, cross-professional staff cannot apply for success or sequelae, I propose to apply for a professional third-party service project of medical devices.cause

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