北京星期三企业管理咨询有限公司业务部
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朝阳青年北京医疗器械三类经营许可证二三类专业快捷包拿证

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。

6.有关部门的行政决定;

7.制证、发证。

办理三类医疗器械经营许可证的条件如下:

1、具有与经营范围相匹配的经营场所和仓库,并对其具体面积有具体要求;

2、具有国家认可的、与经营产品相关专门的在岗人员;

3、具有与经营产品相关的拥有中专以上学历的技术人

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, 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. 6. Administrative decisions of the relevant departments; 7. Making certificates and issuing certificates. The conditions for obtaining the business license of third-class medical devices are as follows: 1. Have a business site and warehouse matching with the business scope, and have specific requirements for its specific area; 2. State-recognized professional personnel related to business products; 3. Technicians with a technical secondary school education or above related to the business products

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