最新医疗器械工作总结.doc

医疗器械工作总结
of rural drinking water sources, protection of drinking water sources in rural areas by the end of thearning signs, isolating network protection facilities
材料经营企业〕
　　二、加强培训，积极引导企业进行GMP改造。
　　积极组织本局工作人员和企业相关人员参加国家和省市局药监部门组织的内审员培训。加强与医疗器械生产企业的日常检查与沟通，提高企业质量标准化管理方面的自律意识。宁波亚太生物技术有限公司针对检查发现要求整改的问题，投入大量资金对公司的空调、水系统进行了全面改造，同时对体外诊断试剂车间也进行了重新布局，并按GMP要求对洁净车间进行了改建。
of rural drinking water sources, protection of drinking water sources in rural areas by the end of the delimitation of the scope of protection, complete with warning signs, isolating network protection facilities
of rural drinking water sources, protection of drinking water sources in rural areas by the end of the delimitation of the scope of protection, complete with warning signs, isolating network protection facilities
of rural drinking water sources, protection of drinking water sources in rural areas by the end of the delimitation of the scope of protection, complete with warning signs, isolating network protection facilities
　　根据药品医疗器械诚信体系建设实施意见，我局在前几年根底上，继续做好监管相对人档案的建立及监管记录等资料的完善工作。
　　三、加大力度，切实加强日常监管。
　　按照年初市局工作会议精神，结合本区实际，制订了医疗器械生产企业日常监督检查方案，有方案、有针对性、有侧重地开展了医疗器械生产、经营企业及医疗机构的日常监督检查。建立企业日常工作联系单制度，随时了解企业生产情况、人员变更情况等。全年共检查检查医疗器械生产企业13家次，其中系统检查6家次，日常检查7家次；检查高风险医疗器械使用单位4家次。
　　及时调整了药品不良反响和医疗器械不良事件监测中心组成人员，同时对各不良反响监测点〔药械生产、经营和使用单位〕的监测员进行了重新登记，加强对医疗器械不良事件的监测。今年市局首次量化了医疗器械不良事件的监测报告任务，要求我区域内的开发区中心医院和宗瑞医院各上报5例。接到任务后，我局屡次与医院
of rural drinking water sources, protection of drinking water sources in rural areas by the end of the delimitation of the scope of protection, complete with warning signs, isolating network protection facilities
of rural drinking water sources, protection of drinking water sources in rural areas by the end of the delimitation of the scope of protection, complete with warning signs, isolating network protection facilities
of rural drinking water sources, protection of drinking water sources in rural areas by the end of the delimitation of the scope of protect