新冠肺炎疫情发生后,广东省药品监督管理局全力做好疫情防控医疗器械的供应保障工作。其中一次性使用医用口罩、新型冠状病毒检测试剂盒、呼吸机、红外体温计等注册证数量居全国首位,为全国乃至全球抗疫做出突出贡献。产业政策上,广东省药品监督管理局先后出台一系列应急审批政策和细化指导文件,优化工作流程,提高审批效率,充分发挥政策导航的作用,加快防疫医疗器械市场准入;监管方面,广东省药品监督管理局严格控制疫情防控医疗器械质量安全,完善疫情防控医疗器械上市后监管手段,严厉打击涉疫情防控用医疗器械的违法犯罪行为,有效保障了疫情防控医疗器械的使用安全。疫情发生也给产业带来新的机遇和挑战,如疫情防控医疗器械或将列入国家的长期战略储备,部分高端产品将更受重视,各类产品将面临优胜劣汰及升级迭代。疫情发生使产业存在的问题凸显,总结经验优化制度、制定人才培养制度、鼓励引导产业高质量发展、提高产业韧性的需求更加迫切。
<<After the outbreak of COVID-19,the Guangdong Medical Products Administration has made every effort to ensure the supply of medical devices for epidemic prevention and control. Among them,the number of disposable medical masks,New COVID-19 test reagent kits,respirators and infrared thermometer registration certificates ranks first in China,it makes the outstanding contributions to the national and global epidemic. In terms of industrial policy,the Guangdong Medical Products Administration has issued a series of emergency approval policies and detailed guidance documents to optimize work procedures,improve technical review and approval efficiency,give full play to the role of policy navigation,and accelerate market access for epidemic prevention equipment;In terms of supervision,the Guangdong Medical Products Administration strictly controls the quality and safety of medical devices for epidemic prevention and control,improves the supervision means on the marketed medical devices for epidemic prevention and control,and severely crack down on the illegal and criminal acts of medical devices used for epidemic prevention and control,effectively ensuring the use safety of epidemic prevention and control devices. The outbreak of COVID-19 also brings new opportunities and challenges to the medical device industry,such as medical devices for epidemic prevention and control or will be included in the national long-term strategic reserve. Some high-end products will be paid more attention,and all kinds of products will face the survival of the fittest and upgrading iteration. The outbreak of COVID-19 also highlights the problems in the medical device industry,it is urgent to summarize the experience optimization system,formulate the personnel training system,encourage the high-quality development of the medical device industry and improve the industry res.
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