那么在北京如何办理三类医疗经营许可证,办理许可证又有哪些条件及流程,小编今天带着满满的干货知识与您分享。
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;
6.经营无菌和植入类产品的公司需建立计算机管理系统及计算机管理制度,能够保证产品从购进到销售整个过程的有效质量跟踪和追溯。
申请医疗器械经营许可证所需材料:
machine, internal fixation equipment, artificial heart valve,artificial kidney, respiratory anesthesia equipment, disposablesterile syringe, disposable infusion set, blood transfusion device,CT, etc. Conditions for applying for the Medical Device BusinessLicense: 1. It shall have a quality management institution orfull-time quality management personnel suitable for the businessscale and business scope. The quality management personnel shallhave the relevant professional academic qualifications orprofessional titles recognized by the state; 2. Having a relativelyindependent business site commensurate with the scale and scope ofbusiness; 3. Having storage conditions suitable with the scale andscope of business, including storage facilities and equipment thatmeet the requirements of the characteristics of medical deviceproducts; 4. The product quality manageme