、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;
(2)工商行政管理部门出具的企业名称预核准证明文件或《营业执照》复印件和校验原件;
(3)企业质量管理负责人的身份证、学历或者职称证明复印件及个人简历;质量管理人员的身份证、学历或者职称证明复印件;
(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
administrative department for industry and commerce; (3) Copy of id card, educational background or professional title certificate and personal resume of the person in charge of quality management of the enterprise; photocopy of id card, educational background or professional title certificate of the quality management personnel; (4) The business site, warehouse of the geographical location plan, plan (indicating the area), the property right certificate or lease copy of the 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 how to handle
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