| 塔娜,李思,李耀华.美国医疗器械上市前通告制度的演变及启示[J].中国药事,2019,33(6):698-704 |
| 美国医疗器械上市前通告制度的演变及启示 |
| The Historical Evolution and Enlightenment of the USA Medical Device Premarket Notification System |
| 投稿时间：2019-01-08 |
| DOI：10.16153/j.1002-7777.2019.06.014 |
| 中文关键词: 医疗器械 上市前通告 历史演变 启示 |
| 英文关键词: medical devices premarket notification historical evolution enlightenment |
| 基金项目: |
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| 中文摘要: |
| 美国是最早立法管理医疗器械的国家，其监管模式的科学性和系统性已被世界上大多数国家和地区认可。本文以美国上市前通告制度为切入点，介绍各项法规的制修订对上市前通告制度带来的变革，以及种种变革对企业注册申请情况的影响，希望能够为我国医疗器械的监管提供启示。 |
| 英文摘要: |
| USA is the earliest country to legislate laws and regulations about medical device administration, whose scientific and systematic regulatory model has already been recognized by most countries and regions in the world. Based on the USA medical device premarket notification system, this article introduces the changes brought about by the revision of various laws and regulations to the premarket notification system, and the impact of various changes on the application for enterprise registration in order to provide enlightenment for the supervision of medical devices in China. |
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