朝阳奥林匹克公园没有人员怎么办北京医疗器械三类经营许可证提供人员库房专业安全包下证

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北京星期三企业管理咨询有限公司业务部
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医疗器械三类
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医疗器械二类
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15501182773
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15501182773
联系人
马胜辉
所在地
北京市海淀区清河嘉园东区甲1号楼11层1124
更新时间
2023-11-04 00:00

详细介绍

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;办理三类医疗器械经营许可证的办理流程:
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员;
4、拥有与经营的医疗器械相适应的质量管理制度很多药品或者医疗器械的经销商,如果没有三类医疗器械经营许可证,很多产品就不能卖,比如说体外诊断试剂就属于三类医疗器械,只有有相关证书,才能销售这种产品。
2、要办理三类医疗器械经营许可证

ments; (2) the relevant departments accept the application ofthe applicant; (3) investigate the actual site and review theproduct; (4) grant the issuance of the third class medical devicelicense.2. legal basis: article 14 of the regulations on thesupervision and administration of medical devices for the filing ofclass i medical devices and the application for the registration ofclass ii and class iii medical devices, the following materialsshall be submitted: (1) product risk analysis data; (2) technicalre of the product; (3) product inspection report; (4)clinical evaluation data; (5) product specification and labelsamples; 1. having the business premises and warehouse matchingwith the business scope, and have specific re for thespecific area; 2, with the state recognized, related to themanagement of products; 3, with a technical secondary schooleducation; 4, with the management of medical devices with the management system of the dealers of many drugs or medicaldevices, without the operating license, a lot of products can't besold, in vitro diagnostic reagents, for example, belong to threecategories of medical devices, only with the relevant certificates,to sell the product.2, to apply for the third class of medicaldevice business license

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