美国医疗器械上市前审批制度介绍及其对我国的启示

Introduction to Premarket Approval System of Medical Devices in the United States and Its Enlightenment to China

目的:通过介绍美国高风险医疗器械产品的上市前审批(PMA)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PMA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PMA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申报路径、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PMA制度的有益做法,对我国监管体系进行不断优化和完善。

Objective:To introduce the premarket approval system for high-risk medical device products in the United States in order to provide references 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.Optimization suggestions on the premarket communication mechanism,modular PMA declaration path and pre-payment process were put forward.Results and Conclusion:The premarket approval system in the United States is the most stringent one among all systems for medical device premarket applications.The modular PMA application method,various communication types and the pre-payment review processes all have great implications for the review and approval system of China’s medical devices.It is suggested that China’s regulatory agencies learn from the beneficial practices of the US medical device premarket approval system and continuously optimize and improve its own regulatory system.