摘要
对一次性使用子宫颈球囊扩张导管产品进行简单介绍,分析该产品在技术审评过程中应关注的要点。
This paper briefly introduced the medical device of Cervical Ripening Balloon Catheter, and next summarized the key points in technical evaluation process.
作者
魏增江
孙兆霞
何泽文
WEI Zeng-jiang;SUN Zhao-xia;HE Ze-wen(Center for Certifcation and Evaluation Guangdong Food ＆ Drug Administration （Guangdong Guangzhou 510080;The First Afliated Hospital of Guangzhou Medical University （Guangdong Guangzhou 510120)
出处
《中国医疗器械信息》
2018年第9期4-5,59,共3页
China Medical Device Information
关键词
子宫颈球囊扩张导管
审评要点
cervical ripening balloon catheter （CRBC）
technical evaluation
