朝阳水碓子北京办理医疗器械三类经营许可证没有库房怎么办包过包下证快捷

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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
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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

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;医疗器械二类备案流程:1、准备执照副本,

(一)具有与经营规模和经营范围相适应的质量管理机构或者质量管理人员两个。质量管理人员应当具有国家认可的相关专业学历或者职称,质量管理人应在职在岗,不得在其他单位兼职;

(二)具有与经营规模和经营范围相适应的相对独立的经营场所;

(三)具有与经营规模和经营范围相适应的储存条件,包括具有符合医疗器械产品特性要求的储存设施、设备;

(四)应当建立健全产品质量管理制度,包括采购、进货验收、仓储保管、出库复核、质量跟踪制度和不良事件的报告制度等;

(五)应当具备与其经营的医疗

business license are as follows: (1) the applicant submits theapplication materials to the relevant departments; (2) the relevantdepartments accept the application of the applicant; (3)investigate the actual site and reviews the products; (4) grant theissuance of the third-class medical device license.2. legal basis:article 14 of the regulations on supervision and administration ofmedical devices for the filing of class i medical devices and theapplication for the registration of class ii and iii medicaldevices, the following materials shall be submitted: (1) productrisk analysis data; (2) product technical re; (3) productinspection report; (4) clinical evaluation data; (5) productdescription and label samples; the filing process of medicaldevices: 1. prepare a copy of the license, (1) it shall have two control agencies or management personnel suitablefor the scale and scope of its business operations. the management personnel shall have the relevant professional educationbackground or professional title recognized by the state, and the manager shall be on duty and shall not take part-time jobsin other units; (2) having a relatively independent business sitecommensurate with the scale and scope of operation; (3) it shallhave storage conditions commensurate with the scale and scope ofbusiness, including storage facilities and e that meet there of the characteristics of the medical device products;(4) the product management system shall be established andimproved, including procurement, purchase and acceptanceinspection, storage, warehouse delivery review, trackingsystem and the reporting system of adverse events; (5) it shallhave the medical treatment it operat

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