(3)到实际场地进行勘察以及对产品进行审核;
(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;
of a class III medical device license. 2. Process for handlingthe business license of Class III Medical Devices: 1. The operatorof the operating 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, t