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。
In Beijing, the application for a Class IIImedical device license requires the following steps: 1. Prepareapplication materials: In accordance with the Regulations onSupervision and Administration of Medical Devices and relevantprovisions, prepare relevant application materials, including thebusiness license of enterprise legal person, product qualitymanagement system documents, product registration certificate,product technical documents, product operation manual, productionlicense, etc. 2. Self-inspection preparation: conductself-inspection of the internal