依据《医疗器械监督管理条例》，第三类医疗器械是具备较高危，必须采用非常对策严控管理方法以确保其安全性、合理的医疗机械。例如普遍的注射器、注射针、静脉留置针、心脏支架、麻醉机、CT、磁共振等。

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。

According to the Regulations on the Supervision and Administration of Medical Devices, the third type of medical devices is a medical machinery with high risk, which must adopt extraordinary countermeasures and strict control management methods to ensure its safety and rationality. For example, common syringes, injection needles, intravenous indwelling needles, cardiac stents, anesthesia, machine, CT, magnetic resonance, etc. Raw materials that must be prepared in advance when 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 m