(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。
actual site and audit the products; (4) Grant the issuance of a class III medical device license. 2. Procedures for handling the business license of Class III medical devices: 1. The operator of the operating enterprise shall apply to the supervision and administration department for the business license with the above information; 2. The staff shall accept the materials and review them within 30 working days, and organize verification if necessary; 3. Grant license and medical device operation license for those who meet the prescribed conditions, and give reasons in writing.