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
3、办理时间:材料受理后的5个工作日
以上就是办理医疗器械许可证需要的资料流程和下证时间,您还需提供以下材料:1、企业名称与经营范围,注册资本及股东出资比例,股东等身份证明;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、身份证明与简历;5、符
ion window shall submit three types of materials (carry theoriginal) and wait for notification and verification 4. Get themedical device license (if there is class II, submit materials, theworld record) Finally, the validity period and period of handlingthe third business license of medical devices are clarified: 1.Effective period of three III: 5 years 2, second class record: novalidity period 3. Processing time: 5 working days after theacceptance of the materials The above is the information processand certification time required for the medical device license, andyou should also provide th