中国食品药品监管Issue(3)：4-13,10.DOI:10.3969/j.issn.1673-5390.2026.03.001
关于创新医疗器械经济学评价的思考
Reflections on the Economic Evaluation of Innovative Medical Devices
摘要
Abstract
As a national strategic emerging industry,the medical device sector has profound implications for public health and industrial competitiveness.China has established a review and approval framework for innovative medical devices through policies such as the Special Review Procedure for Innovative Medical Devices.Nevertheless,the current system faces challenges in accurately assessing clinical value and establishing standardized reimbursement criteria.Health economic evaluation,as a pivotal analytical tool in health policy research,offers a methodological approach to quantify the cost-effectiveness of innovative medical devices and provide evidence-based support for reimbursement decision-making.Through international case comparisons and policy analysis,this paper identifies underlying challenges in China's domestic evaluation system for innovative medical devices and proposes a"tripartite coordination system"featuring"value quantification,dynamic adjustment,and multi-stakeholder collaboration."It aims to explore a value evaluation framework tailored to China's context and provide key references for establishing a scientific and efficient evaluation and decision-making system for innovative medical devices in China.关键词
创新医疗器械/卫生经济学评价/临床价值评估/医保准入/卫生政策研究Key words
innovative medical devices/health economic evaluation/clinical value assessment/medical insurance reimbursement/health policy research分类
医药卫生引用本文复制引用
卢忠,李丹荣,姜明欢,郝丽静,赵明月,周思奇,彭晋,方宇..关于创新医疗器械经济学评价的思考[J].中国食品药品监管,2026,(3):4-13,10.基金项目
国家科技重大专项研究课题(2025ZD0548004) （2025ZD0548004）
2023 年中国药品监督管理研究会课题(2023-Y-Q-012) （2023-Y-Q-012）
广东省重点领域研发计划项目(2025B1111090001) （2025B1111090001）
