北京平谷区时间医疗器械三类经营许可证,医疗器械二类备案办理提供软件省心靠谱
In Beijing, the application for a Class III medical device license requires the following steps: 1. Prepare application materials: In accordance with the Regulations on Supervision and Administration of Medical Devices and relevant provisions, prepare relevant application materials, including the business license of enterprise legal person, product quality management system documents, product registration certificate, product technical documents, product operation manual, production license, etc. 2. Self-inspection preparation: conduct self-inspection of the internal
其次,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
3、办理时间:材料受理后的5个工作日