、第三类医疗器械经营许可证怎么办理
(1)申请人提交申请资料到相关部门;
(2)相关部门受理申请人的申请;
(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;
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。
equipment business license how to handle (1) The applicant shallsubmit the application materials to the relevant departments; (2)Relevant departments shall accept the application of the applicant;(3) Investigate the actual site and audit the products; (4) Grantthe issuance of a class III medical device license. 2. Process forhandling the business license of Class III Medical Devices: 1. Theoperator of the operating enterprise shall bring the aboveinformation to the supervision and administration department toapply for the business license; 2. The staff shall accept thematerials, and review them within 30 working days, and organize theverification if necessary; 3. Grant license and medical deviceoperation license for those who meet the prescribed conditions, andgive reasons in writing. 3. Materials required for handling thebusiness license of Class III medical devices: 1, the enterprisename and business scope, the registered capital and the proportionof shareholder contribution, shareholders and other sfz Ming; 2.Medical device product registration certificate, supplier businesslicense, license and authorization letter; 3. Quality managementdocuments, etc.; 4,2 or more medical professional or relatedprofessional certificates, sfz Ming and resume; 5. Office space andwarehouse certificate that meet the business requirements ofmedical equipment; 6. Articles of association, resolutions ofshareholders' meeting, etc.; 7, financial personnel sfz and workcertificate; 8. Other related materia