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,并有特定的面积要求;
2.具有国家认可的专门从事产品经营的在职人员;
3、应有具有中专以上学历的与产品管理相关的技术人员;
4.具有与所经营的医疗器械相适应的质量管理体系。
许可证的所需材料
1.营业执照;
2.企业负责人、质量检验人员和技术人员的身份、学历和职称证明;
3.营业场所证明和地理位置图。
办理后的注意事项
1.医疗器械经营许可证的有效期只有5年。有效期需要延长的,医疗器械经营企业应当在有效期届满前6个月向原发证部门申请延期《医疗器械经营许可证》
ic knowledge cannot be ignored! In our country, the sales ofmedical equipment must obtain relevant qualifications, so Beijingarea three types of medical equipment business license how tohandle, today we learn it together! What does the business scopeinclude? The business scope of category III medical device licenseincludes: medical electronic equipment, medical optical equipment,instruments and endoscopic equipment, medical magnetic resonanceequipment, medical X-ray equipment, equipment and equipment in theoperating room, emergency room and consulting room. According tothe sale of medical devices must apply for the business license,the relevant national laws and regulations, the US Food and DrugAdministration gradually implement the medical device managementquality standardized management system. The quality managementstandards for medical devices are formulated by the United StatesFood and Drug Administration. Conditions for handling the permitAccording to Article 31 of the Regula