摘要
文章介绍了医疗器械产品技术要求的产生,产品技术要求与产品注册标准的区别。梳理了产品技术要求所涉及的医疗器械各个环节,分析讨论了医疗器械产品技术要求对于整个医疗器械全周期的重要性。
This paper introduced the origin of the Medical Device Technical Requirements(MDTR),and next summarized the differences between MDTER and Production Registered Standard.MDTR thoughts the life cycle of medical device,and plays an essential role in the whole life of medical device.
作者
魏增江
何泽文
WEI Zeng-jiang;HE Ze-wen(Center For Certification and Evaluation Guangdong Food&Drug Administration,Guangdong Guangzhou 510080)
出处
《中国医疗器械信息》
2018年第5期50-52,共3页
China Medical Device Information
关键词
医疗器械产品技术要求
医疗器械全周期
medical device technical requirements(MDTR)
medical device life cycle
