申请医疗器械备案凭证的具体程序:
1、到工商行政管理部门办理营业执照,注册为企业,个体工商户不得办理备案凭证。
3.到质监局办理组织机构代码证。
4.在国家食品药品监督管理局网站上使用组织机构代码注册账户,在线申报。
5.在线提交《医疗器械备案申请表》所需的电子资料。
办理三种医疗器械经营许可证准备必要的处理资料:
(1)《医疗器械经营许可证申请表》;
(2)资格证书;
(3)营业执照或企业名称预先核准证书复印件;
(4)质量管理人员证书;
(5)售后服务人员资格证书。
1.需要办理许可证的企业经营者携带上述材料到当地市级人民政府食品监督管理部门申请营业执照;
2.管理部门受理资料,30个工作日内审核,必要时组织审核;
3.符合条件的,管理部门发行医疗器械经验许可证,不符合条件的,管理部门不予许可,书面说明理由。
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