학술논문
中日医疗器械上市后监管研究 / Research on Medical Device’s Post-marketing Surveillance between China and Japan
Document Type
Academic Journal
Source
中国药物警戒 / Chinese Journal of Pharmacovigilance. 13(9):537-539
Subject
Language
Chinese
ISSN
1672-8629
Abstract
目的：对比中日医疗器械上市后监管方式，为我国医疗器械上市后监测提供参考。方法通过对比中日医疗器械监管机构组成、医疗器械不良事件报告制度及流程、不良事件报告的处理，结合目前我国医疗器械监管现状，分析存在不足，并提出建议。结果目前我国医疗器械上市后监管在法规、企业主体责任意识、使用单位人员能力、公众上报意识方面还存在不足。结论借鉴日本上市后监管经验，改善我国目前监管过程中存在的不足，促进公众用械安全。
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 insufifciencies were analysed, so as to give advices.Results There are still insufifciencies 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.
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 insufifciencies were analysed, so as to give advices.Results There are still insufifciencies 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.