北京怀柔北京医疗器械二类备案医疗器械三类经营许可证专业办理Zui详细的教程快来看

三类医疗器械常见产品有哪些：

植入式心脏起搏器、体外震波碎石机、病人有创监护系统、人工晶体、有创内窥镜、超声手术刀、彩色超声成像设备、激光手术设备、高频电刀、微波缓解仪、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，或者约定由第三方提供技术支持；

l suitable for the business scale and business scope. Thequality management personnel shall have the relevant professionalacademic qualifications or professional titles recognized by thestate; 2. Having a relatively independent business sitecommensurate with the scale and scope of business; 3. Havingstorage conditions suitable for the scale and scope of business,including storage facilities and equipment that meet therequirements of the characteristics of medical device products; 4.The product quality management system shall be established andimproved, including procurement, purchase acceptance, storage,warehouse delivery review, quality tracking and adverse eventreporting system; 5. It shall have the ability of technicaltraining and after-sales service suitable with the medical deviceproducts it