摘要
该文简要介绍了印度医疗器械市场准入的注册程序、应提交的注册文件以及上市后的监管要求。依据印度医疗器械法和医疗器械相关法规,就其对进口医疗器械的注册管理制度进行了初步探讨。旨在为国外医疗器械进入印度市场作为参考。
This paper introduces the premarket registration procedures and the post market regulatory requirements in India. According to Indian medical device act and related medical regulations on medical device, this is a preliminary discussion on the registration management system to provide referance for foreign medical device to enter India market.
出处
《中国医疗器械杂志》
2016年第1期61-63,共3页
Chinese Journal of Medical Instrumentation
关键词
医疗器械
市场准入
印度
medical device
market access
India
