| Status | 已發表Published |
| 中国医疗器械上市后监管现状研究：对发展监管科学的启示 | |
| Alternative Title | Post market surveillance of Medical Device in China: implications for developing regulatory science |
Wang, J. ; Hu, H. ; Ung, O. L. C.
| |
| 2021-09-03 | |
| Source Publication | Reform and Innovation Promoting the Development of Pharmaceutical Care
 |
| Abstract | 中国医疗器械的监管起步相对于药品起步较晚，随着国内医疗器械市场规模的逐渐扩大，国家也正逐步出台相关政策法规以完善国内医疗器械监管体系。近年来随着国内器械监管法规重心逐渐转向全生命周期的监管，上市后监管作为此前稍显薄弱的一环需要得到人们的重视。本研究分析了自2000年“医疗器械监督管理条例”颁布以来我国医疗器械上市后监管政策的发展，和近几年上市后监管中召回及不良事件等指标的变化，希望通过监管科学的手段找到我国医疗器械上市后监管中存在的部分问题并提出相关的改善的建议。 |
| Keyword | 中国 医疗器械 监管 监管科学 |
| Language | 其他語言Others |
| The Source to Article | PB_Publication |
| PUB ID | 60930 |
| Document Type | Conference paper |
| Collection | Institute of Chinese Medical Sciences |
| Corresponding Author | Ung, O. L. C. |
| Recommended Citation GB/T 7714 | Wang, J.,Hu, H.,Ung, O. L. C.. 中国医疗器械上市后监管现状研究：对发展监管科学的启示[C], 2021. |
| APA | Wang, J.., Hu, H.., & Ung, O. L. C. (2021). 中国医疗器械上市后监管现状研究：对发展监管科学的启示. Reform and Innovation Promoting the Development of Pharmaceutical Care. |
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