浅谈韩国对医疗器械市场准入的要求

Requirements of Korea for admittance to medical device market

介绍了韩国医疗器械的定义和分类,结合实际工作经验和国内医疗器械审评要求,分析了选择韩国证书持证人、医院准入、产品上市及上市后的监管等韩国进口医疗器械的几个阶段,为国内和其他国家医疗器械进入韩国市场提供参考。

The concept and classification of Korean medical device were introduced. The phases for Korea to import medical device include selecting Korean certification holder, hospital admittance, device marketing and supervision after marketing. China and other countries can find references to export medical devices into Korea.