加强突发性传染病防控医疗器械监管体系的建设

Strengthening the Regulatory System for Sudden Infectious Diseases Prevention and Control Use Medical Devices

近年来,全球频发突发性传染病疫情,公共卫生防治面临严峻挑战。本文回顾了国家食品药品监督管理总局对防治突发性传染病的防控医疗器械在上市前审批和上市后监管的应对情况,介绍了近年来国家食品药品监督管理总局在应对各种突发性传染病疫情中不断加强防控医疗器械监管体系构建的情况,并对该监管体系建设的未来发展进行了展望。

In recent years, epidemic diseases outbreak suddenly and frequently all over the world, and continu-ously challenging public health dealing system. This paper reviewed the efforts of the China Food and Drug Ad-ministration（CFDA） on the pre-market approval and post-marketing supervision of the medical devices in prevent-ing and controlling sudden infectious diseases, and on the building and strengthening the regulatory system for themedical devices, and looks into the futural development of the regulatory system.