申请办理三类医疗器械许可证必须提前准备的原材料

（1）企业营业执照；

（2）公司章；

（3）房屋产权证明、租赁协议；

（4）法定代表人、主要负责人、品质管理员的身份、毕业证等证明材料；

（5）经营地平面设计图，仓库平面设计图。

申请办理三类医疗器械许可证的规定

（1）场所和仓库总面积规定：与经营地企业规模相一致。

（2）品质管理员规定：专科本科以上学历或是初级左右专业职称，另外理应具备3年左右医疗器械经营品质管理方面亲身经历。

（3）品质管理员技术专业规定：医疗机械有关技术专业，例如：医药学、药理学、生物技术、护理专业等。

applying for the Class III medical device license (1) Enterprise business license; (2) Company seal; (3) Property right certificate and lease agreement; (4) Identity of legal representative, principal person in charge, quality manager, graduation certificate and other certification materials; (5) Business floor plan design drawing, warehouse floor plan design drawing. Provisions on applying for a class III medical device license (1) The total area of the place and warehouse: consistent with the scale of the enterprise in the operating place. (2) Quality administrator regulations: college degree or above or junior professional title, in addition, should have about 3 years of personal experience in medical devic