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
通州马驹桥医疗器械三类经营许可证二类备案专业办理快捷包下证

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;

(六)与产品研制、生产有关的质量管理体系文件;

(七)证明产品安全、有效所需的其他资料。

(1)提交医疗器械经营企业许可证申请表,法定代表人签字或加盖企业公章;

(2)工商行政管理部门出具的企业名称预核准证明文件或《营业执照》复印件和校验原件;

(3)企业质量管理负责人的身份证、学历或者职称证明复印件及个人简历;质量管理人员的身份证、学历或者职称证明复印件;

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; (6) quality management system documents related to product development and production; (7) other materials required to prove the safety and effectiveness of the product. (1) Submit the application form for the license of the medical device trading enterprise, signed by the legal representative or affix the official seal of the enterprise; (2) The copy of the pre-approval certificate of enterprise name or the business License issued by the administrative department for industry and commerce; (3) a copy of the id card, educational background or professional title certificate and personal resume of the quality management manager of the enterprise; a copy of the id card, educational background or professional title certificate of the quality management personnel;

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