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美国医疗器械上市前审批制度介绍及其对我国的启示塔娜,李耀华 |
Introduction of Premarket Approval of American Medical Devices and Its Enlightenment to China |
投稿时间:2020-02-20 修订日期:2020-04-14 |
DOI: |
中文关键词: 医疗器械 上市前审批 申报方式 审评流程 沟通交流 启示 |
英文关键词: medical device premarket approval enlightenment |
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中文摘要: |
摘要 目的:通过介绍美国高风险医疗器械产品的上市前审批制度,希望对我国医疗器械审评审批制度的完善提供参考。方法:从申报方式、审评流程、沟通交流渠道等方面对美国高风险医疗器械产品的上市前审批制度进行介绍,并就事前沟通机制、模块化PMA申报路径和缴费流程前置等提出优化建议。。结果与结论:美国上市前审批制度是医疗器械上市申报方式中最为严格的制度。其中,模块化PMA申报方式、多种交流渠道和缴费前置的申报流程均对我国医疗器械审评审批制度有较大参考价值。建议我国监管机构能够借鉴美国医疗器械上市前制度的有益做法,对我国监管体系进行不断优化和完善。 |
英文摘要: |
Abstract Objective: By introducing the premarket approval system for high-risk medical device products in the United States, we hope to provide reference for the improvement of China"s medical device review and approval system. Methods: The premarket approval system of high-risk medical device products in the United States was introduced in terms of application methods, review processes, and communication types. Results and conclusion: The premarket approval system in the United States is the most stringent system for medical device premarket applications. Through the introduction of this article, the modular PMA application method, communication types and pre-payment review process all have great implications for China"s medical device review and approval system. It is suggested that China"s regulatory agencies can learn from the beneficial practices of the US medical device premarket approval system and optimize and improve its own regulatory system. |
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