海淀牡丹园北京医疗器械三类经营许可证,医疗器械二类备案提供人员库房专业快捷包下证

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北京星期三企业管理咨询有限公司业务部  
医疗器械三类
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医疗器械二类
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网络销售备案
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联系人
马胜辉(先生)
手机
15501182773
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15501182773
发布日期
2023-12-18 11:21
编号
12960726
发布IP
114.246.180.135
区域
北京公司注册
地址
北京市海淀区清河嘉园东区甲1号楼11层1124
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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;
(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。4、工商行政管理部门出具的《企

8、申请材料真实性的自我保证声明应由法定代表人签字并加盖企业公章,如无公章,则须有法定代表人本人签字或签章。

9、凡申请材料需提交复印件的,申请人

applicant submits the application materials to the relevant departments; (2) the relevant department accepts the application of the applicant; (3) investigate the actual site and review the product; (4) grant the issuance of the Class III medical device license.2. Legal basis: Article 14 of the Regulations on Supervision and Administration of Medical Devices for the filing of Class I medical devices and application for the registration of Class II and III medical devices shall submit the following materials: (1) product risk analysis data; (2) technical requirements (3) product; (3) product inspection report; (4) clinical evaluation data; (5) product instructions 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.4, the enterprise issued by the administrative department for industry and commerce 8. The self-guarantee statement of the authenticity of the application materials shall be signed by the legal representative and affixed with the official seal of the enterprise. If there is no official seal, there shall be the signature or signature of the legal representative himself. 9. If the application materials need to be submitted with a photocopy, the appl



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