关键词: 中日, 医疗器械, 上市后监管, 研究

Abstract: Objective Comparing medical device’s post-marketing surveillance between China and Japan, to provide reference for the medical device’s post-marketing monitoring in China. Methods Through the comparison between Chinese and Japanese medical device regulatory agency composition, medical device adverse event reporting system and procedures, treatment of medical device adverse event reports, combining with Chinese medical device regulatory status, the existing insufficiencies were analysed, so as to give advices. Results There are still insufficiencies in regulation, corporate responsibility awareness, the ability of hospital personnel, and public awareness. Conclusion By learning the medical device’s post-marketing surveillance in Japan, Chinese current regulation can be improved to promote the public safety of medical device’s use.

Key words: China and Japan, medical device, post-marketing surveillance, research