在突发公共卫生事件或其他严重威胁公众健康的紧急事件出现时,药品、医疗器械等医疗产品的供给是有效应对紧急事态的重要保障。尽管我国建有医疗器械应急审批程序、优先审批程序及创新医疗器械特别审查程序、临床试验拓展性应用以及附条件审批等多种医疗器械应急管理制度,但由于各种程序都具有定位偏差和局限性,这些程序尚不能完全满足紧急情形下的用械需求。为此,要在紧急情形下保障医疗器械的供给,未来既要完善现行的医疗器械应急审批制度,又要构建新的医疗器械紧急授权使用制度。
<<In public health emergencies or other emergencies that seriously threaten public health,the supply of medicine,medical devices and other medical products is an important guarantee to effectively respond to emergencies. Although there are many systems to realize the accessibility of medical devices in China,such as Emergency Approval Procedures,Priority Approval Procedures,Special Review Procedures for Innovative Medical Devices,Expansion Applications in Clinical Trial,and Conditional Approval,etc.,but due to the different goals and limitations of various procedures,they can not fully meet the needs of medical devices in emergency. Therefore,in order to achieve the accessibility of medical devices in emergency situations,we should not only improve the current emergency approval system of medical devices,but also build a new system of Emergency Use Authorizations about medical devices in the future.
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