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
seal 3. Copy of the office and warehouse room 4. Personnel(mainly the quality manager and the supervisor inspector) Amongthem, quality manager: required college graduation for three yearsSupervisor inspector: required to graduate for three years oflaboratory related major Secondly, the following procedures shouldbe completed for the third business license of medical devices: 1,the business scope should have "sales of medical devices" 2. Submitmedical device materials online application 3. The drugadministration window shall