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。
Class III medical devices: 1, the enterprise name and business scope, the registered capital and the proportion of shareholder contribution, shareholders and other sfz Ming; 2. Medical device product registration certificate, supplier business license, license and authorization letter; 3. Quality management documents, etc.; 4,2 or more medical professional or related professional certificates, sfz Ming and resume; 5. Office space and warehouse certificate that meet the business requirements of medical equipment; 6. Articles of association, resolutions of shareholders' meeting, etc.; 7, financial personnel sfz and work certificate; 8. Other related materials.