二、第三类医疗器械经营许可证办理流程:
1、经营企业经办人携带上述资料前往监督管理部门申请经营许可;
2、工作人员受理资料,并于30个工作日内进行审查,必要时组织核查;
3、对符合规定条件的,准予许可并发给医疗器械经营许可证;对不符合规定条件的,不予许可并书面说明理由。
三、第三类医疗器械经营许可证办理所需材料:
1、企业名称与经营范围,注册资本及股东出资比例,股东等sfz明;
2、医疗器械产品注册证书、供应商营业执照、许可证及授权书;
3、质量管理文件等;
4、2个或以上医学专业或相关专业人员证书、sfz明与简历;
5、符合医疗器械经营要求的办公场地及仓库证明;
6、公司章程、股东会决议等;
7、财务人员sfz和上岗证;
8、其它相关材料。
l devices: 1. The operator of the operating enterprise shallapply to the supervision and administration department for thebusiness license with the above information; 2. The staff shallaccept the materials and review them within 30 working days, andorganize verification if necessary; 3. Grant license and medicaldevice operation license for those who meet the prescribedconditions, and give reasons in writing. 3. Materials required forhandling the business license of Class III medical devices: 1, theenterprise name and business scope, the registered capital and theproportion of shareholder contribution, shareholders and other sfzMing; 2. Medical device product registration certificate, supplierbusiness license, license and authoriza