湖南医疗器械经营许可证代办
医疗器械经营许可证怎么办理?
1、办理条件:
(1)具有与经营的医疗器械相适应的质量保证体系或者质量管理制度;有与经营的医疗器械相应的注册证书或者备案凭证、生产许可证、产品说明书和包装标识;符合法律、行政法规和规章规定的其他条件。
(2)企业负责人应当具备与其经营规模、经营业绩相匹配的任职能力;熟悉相关法规、规章及标准规范;无不良诚信记录。
(3)具有与经营的医疗器械品种、数量相适应的经营场所和贮存条件,并与其他区域有效隔离;通风良好;环境整洁;与生活区有效隔离。
2、申请材料:
(1)《药品经营许可证》申请表;
(2)企业法定代表人或者负责人身份证明;
(3)办公场所以及仓库的使用证明;
(4)质量管理人员学历证书,职称证,技能等级证,身份证;
(5)设备设施目录;
(6)仓储设施,包括库房面积,层数,高度,消防设施,温湿度监测设备等等;
(7)计算机信息管理系统说明材料;
(8)依法需要提交的其他有关资料。
3、审批程序:
申请人将填写好的《药品经营许可证》申请表,以及上述所列全部申办材料交至当地药监部门进行审核,经形式审查合格,发给《受理通知书》,然后按照要求缴纳各项费用,领取或补领营业执照即可。
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