摘要
泰国和印度尼西亚蓬勃发展“医疗旅游”产业为我国医疗器械企业提供了一个很大的医疗器械市场,掌握两国的市场准入需求至关重要。通过系统的法规梳理及调研,介绍泰国和印尼医疗器械的监管部门和分类,分析两国医疗器械市场准入注册流程,梳理不同类别医疗器械注册时需提交的文件,同时,两国对医疗器械标签标识的要求和医疗器械上市后监管措施进行阐述解析。最终总结分析在医疗旅游影响下两国医疗器械市场准入特点,为我国医疗器械顺利进入泰国和印度尼西亚市场提供参考和借鉴。
The booming“medical tourism”in Thailand and Indonesia is a new lucrative arena for medical devices.Based on this background,it is very important to figure out the market access requirements in both countries.Combining systematically regulation analysis and research,regulatory authorities,definition and classification of medical devices in Thailand and Indonesia were introduced.Registration procedures for market access of imported medical devices in both countries were analyzed.Documents to be submitted for the application of medical devices registration had been sorted out.Requirements on the labeling of medical devices as well as post-marketing surveillance were represented.This paper simply analyzed the market access of medical devices in both countries in the context of medical tourism and provides references for chinese medical devices to access to the market of Thailand and Indonesia.
作者
张坤智
晁园
谢昕
郑超
王越
甄辉
ZHANG Kun-zhi;CHAO Yuan;XIE Xin;ZHENG Chao;WANG Yue;ZHEN Hui(Zhejiang Center for Medical Device Evaluation,Zhejiang Hangzhou 311121)
出处
《中国医疗器械信息》
2020年第19期1-3,11,共4页
China Medical Device Information
基金
浙江省食品药品监管系统科技计划项目(项目名称:东盟十国医疗器械市场准入监管研究,项目编号:2019018)。
关键词
医疗旅游
医疗器械
市场准入
medical tourism
medical devices
market access
