朝阳团结湖北京医疗器械二类备案医疗器械三类经营许可证全程托管省心安全Zui快七天下证

医用核磁共振成像设备、X线缓解设备、医用高能设备、人工心肺机、内固定器材、人工心脏瓣膜、人工肾、呼吸麻醉设备、一次性使用无菌注射器、一次性使用输液器、输血器、CT等。

三类申请医疗器械经营许可证条件：

1.具有与经营规模和经营范围相适应的质量管理机构或者专职质量管理人员。质量管理人员应当具有国家认可的相关专业学历或者职称；

2.具有与经营规模和经营范围相适应的相对独立的经营场所；

3.具有与经营规模和经营范围相适应的储存条件，包括具有符合医疗器械产品特性要求的储存设施、设备；

4.应当建立健全产品质量管理制度，包括采购、进货验收、仓储保管、出库复核、质量跟踪和不良事件的报告制度等；

5.应当具有与其经营的医疗器械产品相适应的技术培训和售后服务的能力，或者

ions for applying for the Medical Device Business License: 1. It shall have a quality management institution or full-time quality management personnel suitable for the business scale and business scope. The quality management personnel shall have the relevant professional academic qualifications or professional titles recognized by the state; 2. Having a relatively independent business site commensurate with the scale and scope of business; 3. Having storage conditions suitable for the scale and scope of business, including storage facilities and equipment that meet the requirements of the characteristics of medical device products; 4. The product quality management system shall be established and improved,