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朝阳芍药居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

发布时间:2023-12-18        浏览次数:3        返回列表
前言:医疗器械三类,注册公司
朝阳芍药居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

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;办理三类医疗器械经营许可证的办理流程:

(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

(4)经营场所、仓库的地理位置图、平面图(注明面积)、房屋产权证明或者租赁协议复印件;

(5)企业产品质量管理制度文件及储存设施、设备目录。

(6)对于办理三类医疗器械经营许可证内容包含有需要冷藏的药品时,企业具备的运输装备、仓储设施设备情况表。

、第三类医疗器械经营许可证怎么办理

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;

of Medical Devices for product filing of Class I medical devices and application for product registration of Class II and Class III medical devices, the following materials shall be submitted: (1) product risk analysis data; (2) technical requirements of the product; (3) product inspection report; procedures for handling the business license of Class III medical devices: (4) A product quality management system shall be established and improved, including procurement, purchase and acceptance, storage and out of storage (4) The business site and the warehouse of the geographical location map, the floor plan (indicating the area), the house property right certificate or the copy of the lease agreement; (5) Enterprise product quality management system documents and catalogue of storage facilities and equipment. (6) Table of transportation equipment and storage facilities and equipment available by the enterprise when the contents of the business license contains drugs that need to be refrigerated. , The third type of medical equipment business license


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