(4)准予颁发三类医疗器械许可证。
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;
ical device license. 2. Process for handling the businesslicense of Class III Medical Devices: 1. The operator of theoperating enterprise shall apply to the supervision andadministration department for the business license with the aboveinformation; 2. The staff shall accept the materials, and reviewthem within 30 working days, and organize the verification ifnecessary; 3. Grant license and medical device operation licensefor those who meet the prescribed conditions, and give reasons inwriting. 3. Materials required for handling the business license ofClass III medical devices: 1, the enterprise name and businessscope, the registered capita