卫生技术评估（Health Technology Assessment, HTA）在我国药品管理政策中的制度化应用不断深化,但其在医疗器械领域的应用仍存在滞后性。当前,HTA对医疗器械的评估实践仍处于政策试点与区域性实践的探索萌芽阶段,在上市监管、上市后再评估、目录管理和支付管理等关键环节存在系统性挑战,必要的政策联动不足。基于此,本文旨在分析我国医疗器械管理现状,通过国际经验总结,提出以HTA为理论基础的医疗器械管理建议,促进构建“三医”协同的医疗器械治理体系,希望可以助力我国统筹建立“全国一盘棋”的医疗器械全生命周期管理机制。
Abstract
Health technology assessment (HTA) has been increasingly institutionalized in China's drug management policy, yet its application in the medical device sector remains underdeveloped. Current HTA practice for medical devices is still in the nascent phase of policy pilots and regional practice, with systemic challenges and insufficient necessary policy linkage persisting across critical stages, including market regulation, post-market reassessment, catalog management, and payment management. Therefore, this study analyzes the status quo of medical device governance in China and synthesizes international practice to propose medical device management recommendations based on HTA value assessment theory and to promote the construction of a medical device governance system that enhances the coordinated development and regulation of medical insurance, medical services, and pharmaceuticals. The findings aim to facilitate the establishment of a nationally coordinated whole life cycle governance mechanism for medical devices.
关键词
卫生技术评估 /
医疗器械 /
全生命周期 /
“三医”协同
Key words
health technology assessment /
medical devices /
whole life cycle /
coordinated development and regulation of medical insurance,medical services,and pharmaceuticals
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参考文献
[1] 张刚.证券研究报告——晨会聚焦[EB/OL].(2025-01-17)[2025-03-21].http://www.glybw.com/doc-5eff3e44a53ff2cc3715b0ca1591f93f.html.
[2] RESEACH B. Medical devices: technologies and global markets2024[EB/OL].(2024-10-01)[2025-03-21].https://www.bccresearch.com/market-research/healthcare/medical-devices-technologies-and-global-markets.html?srsltid=AfmBOopUO2TWVtaBRoskJEcnMz4eySsG9r86wRmHQkiAw0WPO8U4XZ4D.
[3] 解放日报.我国医疗器械产业规模稳居全球第二2024医疗器械经济信息发布会在沪召开[EB/OL].(2024-11-21)[2025-03-28].https://www.shanghai.gov.cn/nw4411/20241121/fa1f7c20c0ac4e77a7649b37d0a866a3.html.
[4] 国家药品监督管理局. 2024年度医疗器械注册工作报告[EB/OL].(2025-02-14)[2025-04-11].https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjylqx/20250213095700131.html.
[5] 人民日报.创新药品和医疗器械上市步伐加快——促进医药产业高质量发展[EB/OL].(2024-09-17)[2025-04-19].https://www.gov.cn/lianbo/bumen/202409/content_6974970.htm.
[6] 海南省医疗保障局.关于印发《海南省支持创新药械发展的若干措施》的通知[EB/OL].(2024-01-05)[2025-03-22].https://ybj.hainan.gov.cn/xxgk/xxgkml/202401/t20240105_3564828.html.
[7] 上海市人民政府.关于印发《上海市进一步完善多元支付机制支持创新药械发展的若干措施》的通知[EB/OL].(2023-07-28)[2025-03-22].https://www.shanghai.gov.cn/gwk/search/content/6f30a84882fa4fac982feabd31121a56.
[8] 广州市医疗保障局.广州市医疗保障局关于印发广州医保支持创新医药发展若干措施的通知[EB/OL].(2024-05-16)[2025-03-22].https://www.gz.gov.cn/gzybj/gkmlpt/content/9/9658/mpost_9658982.html#14462.
[9] 上海市人民政府办公厅.关于支持生物医药产业全链条创新发展的若干意见[EB/OL].(2024-07-30)[2025-03-22].https://www.shanghai.gov.cn/nw12344/20240730/0fe29fc2246e4b478757dee3a01ccd08.html.
[10] 国家药监局综合司.关于印发2025年医疗器械行业标准制修订计划项目的通知[EB/OL].(2025-03-20)[2025-03-28].https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjylqx/20250319162322178.html.
[11] 中共中央办公厅,国务院办公厅.关于深化审评审批制度改革鼓励药品医疗器械创新的意见[EB/OL].(2017-10-08)[2025-03-22].https://www.gov.cn/gongbao/content/2017/content_5232362.htm.
[12] 国家医疗保障局.国家医疗保障局对十三届全国人大五次会议第8013号建议的答复[EB/OL].(2022-08-24)[2024-11-15].https://www.nhsa.gov.cn/art/2022/8/24/art_110_8885.html.
[13] 张晓路,李睿,郭武栋,等.卫生技术评估助力中国建设多层次医疗保障体系[J].健康发展与政策研究,2024,27(02):112-119.
[14] 国家卫生健康委.国家卫生健康委关于开展药品使用监测和临床综合评价工作的通知[EB/OL].(2019-04-09)[2025-03-23].http://www.nhc.gov.cn/yaozs/pqt/201904/31149bb1845e4c019a04f30c0d69c2c9.shtml.
[15] 中国健康传媒集团.中国医疗器械蓝皮书[M].北京:中国医药科技出版社,2021.
[16] 国家医疗保障局.关于做好基本医疗保险医用耗材支付管理有关工作的通知[EB/OL].(2023-07-21)[2025-03-31].https://www.nhsa.gov.cn/art/2023/9/5/art_104_11226.html.
[17] 国家药品监督管理局.关于优化全生命周期监管支持高端医疗器械创新发展的举措(征求意见稿)[EB/OL].(2025-03-31)[2025-03-31].https://www.nmpa.gov.cn/xxgk/zhqyj/zhqyjylqx/20250331145952112.html.
[18] ISPOR. Review of health technology assessment guidelines worldwide[EB/OL].(2024-01-15)[2025-03-05].https://www.ispor.org/docs/default-source/euro2024/hta-guidelines-hta331143022-pdf.pdf?sfvrsn=661d7364_0.
[19] 宁德市医疗保障局. 当今国际上主要的医疗保障模式及对我国的启示[EB/OL]. (2022-10-24)[2025-06-04]. https://ybj.ningde.gov.cn/gzzl/gzdt/202210/t20221024_1670533.htm.
[20] Interreg NWE. Guidance document-Classification of medical devices[EB/OL].(2010-06-09)[2025-04-15]. https://vb.nweurope.eu/media/3205/ce-marking_guidance-classification-of-medical-devices_en.pdf.
[21] Ministry of Health LAW. Regenerative medicine promotion act[EB/OL].(2013-04-26)[2025-04-11]. https://www.mhlw.go.jp/english/policy/health-medical/medical-care/dl/150407-01.pdf.
[22] 明坚,魏艳,何运臻,等.医疗器械和诊断产品的卫生技术评估路在何方——基于国际经验的启示[J].中国医疗保险,2021(06):69-74.
[23] FRIEDICH GRAF. Special approvals for medical devices[EB/OL]. (2020-07-31)[2025-04-25]. https://www.fgvw.de/en/news/archive-2020/special-approvals-for-medical-devices.
[24] MHRA. The medical devices (post-market surveillance requirements) (amendment) (Great Britain) regulations2024: guidance on implementation[EB/OL]. (2025-01-15)[2025-04-19]. https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/the-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024-guidance-on-implementation.
[25] NICE. Medical technologies evaluation programme process guide[EB/OL]. (2017-08-21)[2025-04-17]. https://www.nice.org.uk/process/pmg34/chapter/introduction.
[26] CNEDiMTS. National Committee for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS)[EB/OL]. (2024-05-06)[2025-04-06]. https://www.has-sante.fr/jcms/c_2036238/en/national-committee-for-the-evaluation-of-medical-devices-and-health-technologies-cnedimts.
[27] 李佳明,杨烁,孟凡月,等.日本医用耗材医保目录管理研究[J].中国医院,2024,28(05):50-54.
[28] 邱英鹏,赵羽西,赵翔,等.澳大利亚假体类高值医用耗材医保准入管理经验及启示[J].中国卫生质量管理,2021,28(05):12-15.
[29] ISPOR. Health technology assessment and reimbursement of medical devices in England, France,Germany[EB/OL]. (2022-11-06)[2025-04-16]. https://www.ispor.org/docs/default-source/euro2022/heptinstall-et-alhta243ispor-2022-pdf.pdf?sfvrsn=ab1b900d_0.
[30] 吕兰婷,余浏洁.英国NICE医用耗材准入流程及启示[J].中国医疗保险,2019(10):77-80.
[31] BfArM. Medical device registration in Germany[EB/OL]. (2023-08-01)[2025-04-11]. http://www.thema-med.com/en/medical-device-registration-in-germany/.
[32] HAS. Pathway of medical devices in France[EB/OL]. (2017-11)[2025-04-17]. https://www.has-sante.fr/jcms/c_930909/en/pathway-of-medical-devices-in-france-practical-guide.
[33] 蔺淼,李佳明,丁锦希,等.澳大利亚私人健康保险医用耗材目录制定研究与启示[J].中国医院, 2022,26(07):64-67.
[34] NHS. National supply system for high-cost tariff-excluded devices[EB/OL]. (2016-04)[2025-04-11]. https://www.england.nhs.uk/commissioning/spec-services/key-docs/medical-devices/.
[35] G-BA. Richtlinie Methoden Krankenhausbehandlung[EB/OL]. (2025-03-20)[2025-04-17]. https://www.g-ba.de/richtlinien/34/.
[36] SYSTEM G M A. Happy with your knowledge on the reimbursement of medical devices in Germany?[EB/OL]. (2022-02-14)[2025-04-18]. https://germanmarketaccesssimplified.com/reimbursement-of-medical-devices-in-germany/.
[37] MARTIN T, HERVIAS A, ARMOIRY X, et al.Early access programs for medical devices in France: overview of recent reforms and outcomes (2015-2022)[J]. Health policy, 2024,148:105146.
[38] 丁颖田,傅孟元,韩晟,等.关于促进进口创新医疗器械在我国同步上市的政策思考[J].中国食品药品监管,2024(02):50-65.
[39] 张誉铮,王培蒙,贾梦婷,等.我国医保医用耗材目录及支付管理政策分析[J].中国卫生经济, 2025,44(02):34-40.
[40] 国家医疗保障局.《基本医疗保险医用耗材管理暂行办法(征求意见稿)》公开征求意见[EB/OL]. (2020-06-08)[2025-04-21]. https://www.nhsa.gov.cn/art/2020/6/8/art_113_7126.html.
[41] 北京市医疗保障局.关于印发CHS-DRG付费新药新技术除外支付管理办法的通知(试行)[EB/OL]. (2022-07-13)[2025-04-27]. https://ybj.beijing.gov.cn/tzgg2022/202207/t20220713_2798069.html.
