北京星期三企业管理咨询有限公司业务部
工商注册 , 资质审批 , 代理记账 , 建委资质 , 舞美资质 , 拍卖资质
朝阳石佛营北京医疗器械二类备案医疗器械三类经营许可证专业办理经验丰富安全时效快可靠快捷

在我国经营销售医疗器械必须取得相关资质,那么北京地区三类医疗器械经营许可证如何办理,今天我们一起学习一下吧!

经营范围包括哪些?

第三类医疗器械许可的经营范围包括:医用电子设备、医用光学设备、仪器和内镜设备、医用磁共振设备、医用X射线设备、手术室、急诊室和诊室的设备和器具。根据售卖医疗器械必须办理经营许可证,,国家相关法律法规,美国食品药品监督管理局逐步推行医疗器械管理质量标准化管理体系。医疗器械经营质量管理规范由国家美国食品药品监督管理局制定。

许可证的办理条件

根据《医疗器械监督管理条例》第三十一条的规定,从事第三类医疗器械业务的,经营企业应当向所在地设区的市级人民政府食品药品监督管理部门申请经营许可。

1.有与经营范围相适应的营业场所和仓库,并有特定的面积要求;

In our country, the sales of medical equipment must obtain relevant qualifications, so Beijing area three types of medical equipment business license how to handle, today we learn it together! What does the business scope include? The business scope of category III medical device license includes: medical electronic equipment, medical optical equipment, instruments and endoscopic equipment, medical magnetic resonance equipment, medical X-ray equipment, equipment and equipment in the operating room, emergency room and consulting room. According to the sale of medical devices must apply for the business license, the relevant national laws and regulations, the US Food and Drug 


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