我们必须清楚办理医疗器械三类经营许可证需要哪些资料;
1、公司执照正副本
2、公章
3、办公和库房房本复印件
4、人员(主要是质量管理人和主管检验师)
其中 质量管理人:要求大专毕业满三年
主管检验师:要求本科毕业满三年 检验学相关专业
办理医疗器械三类经营许可证要完成以下流程:
1、经营范围要有“销售医疗器械”
2、网申提交医疗器械材料
3、药监窗口提交三类材料(携带原件),等待通知核查
4、领取医疗器械许可证(若有二类,提交材料,当天下备案单)
Zui后明晰办理医疗器械三类经营许可证有效期、办理期限:
1、三类的有效期限:5年
2、二类备案单:没有有效期
econdary copy 2. Official seal 3. Copy of the office andwarehouse room 4. Personnel (mainly the quality manager and thesupervisor inspector) Among them, quality manager: required collegegraduation for three years Supervisor inspector: required tograduate for three years of laboratory related major Secondly, thefollowing procedures should be completed for the third businesslicense of medical devices: 1, the business scope should have"sales of medical devices" 2. Submit medical device materialsonline application 3. The drug administration window shall submitthree types of materials (carry the original) and wait fornotification and verification 4. Get the medical device license (ifthere is class II,