医疗器械强制性上市后研究相关制度分析

doi:10.19803/j.1672-8629.20250617

摘要/Abstract

摘要： 目的探讨批准后研究（PAS）和522上市后监测研究（522研究）制度开展情况,为我国医疗器械强制性上市后研究制度提供参考。方法采用横断面研究方法,对美国食品药品监督管理局（FDA）网站公开的PAS数据库和522研究数据库中研究项目进行统计,对比两者在基本情况、研究设计、完成情况及结果应用等方面的差异,并结合我国相关制度现状开展分析。结果共纳入PAS研究（1991—2025年）970项,522研究（2001—2025年）409项。PAS主要针对经上市前审批（PMA）途径批准的Ⅲ类高风险器械（96.19%）,研究设计以前瞻性队列研究为主（65.05%）,完成率较高（57.73%）;522研究主要针对经510(k)途径批准的Ⅱ类器械（92.9%）,研究设计以横断面研究为主（21.03%）,完成率较低（12.47%）。2项制度的研究成果均有效应用于产品标签更新和监管决策,但也面临研究成本高昂、响应滞后、数据透明度不足等挑战。结论建议我国在现行法规制度要求下,进一步结合监管实践,完善细化强制性上市后研究法规体系,加强执行过程控制与研究成果转化。

关键词: 医疗器械, 上市后研究, 批准后研究, 522上市后监测研究, 美国食品药品监督管理局, 监管科学

Abstract: Objective To find out about the implementation of the Post-Approval Studies (PAS) and Section 522 Postmarket Surveillance Studies programs, and to provide insights into the regulatory framework of China's counterparts. Methods A cross-sectional analysis was conducted. Data from the FDA’s official PAS and 522 study databases was analyzed. The basic characteristics, study designs, programs completed, and applications of findings were compared between the two systems. The findings were then analyzed in light of the current regulatory landscape in China. Results A total of 970 PAS (1991-2025) and 409 522 Studies (2001-2025) were included. The PAS primarily targeted Class Ⅲ high-risk devices approved via the Premarket Approval (PMA) pathway (93.3%). The study designs were predominantly prospective cohorts (65.05%), demonstrating a relatively high rate of completion (57.73%). In contrast, the 522 studies involved Class Ⅱ devices cleared via the 510(k) pathway (92.9%). Their design was primarily cross-sectional (21.03%), with a low rate of completion (12.47%). Findings from both programs were effectively used for label updates and regulatory decision-making, yet challenges like high costs, delayed reactions, and insufficient transparency of data persisted. Conclusion It is recommended that China, within its existing regulatory framework, continue to refine and elaborate its mandatory postmarket study regulations based on practical oversight experience in order to facilitate execution control and the transformation of research findings.

Key words: Medical Devices, Postmarket Studies, Post-Approval Study (PAS), Section 522 Postmarket Surveillance Studies, FDA, Regulatory Science

中图分类号:

R951

李栋, 张龙瑛, 沈晓华, 刘张嫔, 吴正善, 赵燕. 医疗器械强制性上市后研究相关制度分析[J]. 中国药物警戒, 2025, 22(12): 1383-1387.

LI Dong, ZHANG Longying, SHEN Xiaohua, LIU Zhangpin, WU Zhengshan, ZHAO Yan. Mandatory Post-Market Studies of Medical Devices[J]. Chinese Journal of Pharmacovigilance, 2025, 22(12): 1383-1387.

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