随着国民经济的稳步发展和人们对医疗健康的广泛关注,医疗行业成为众多投资伙伴关注的焦点。想要涉足医疗器械领域,这些基础知识是不能忽视的!
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
al devices, these basic knowledge cannot be ignored! In ourcountry, the sales of medical equipment must obtain relevantqualifications, so Beijing area three types of medical equipmentbusiness license how to handle, today we learn it together! Whatdoes the business scope include? The business scope of category IIImedical 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 andconsulting room. According to the sale of medical devices mustapply for the business license, the relevant national laws andregulations, the US Food and Drug Administration graduallyimplement the