新时代构建我国医疗器械警戒体系的思考

doi:10.19803/j.1672-8629.2022.07.01

中国药物警戒 ›› 2022, Vol. 19 ›› Issue (7): 697-701.
DOI: 10.19803/j.1672-8629.2022.07.01

新时代构建我国医疗器械警戒体系的思考

沈传勇, 宋雅娜, 赵燕, 郑立佳, 赵一飞, 李栋

国家药品监督管理局药品评价中心,国家药品监督管理局药物警戒研究与评价重点实验室,北京 100022

收稿日期:2022-03-11 出版日期:2022-07-15 发布日期:2022-07-12
作者简介:沈传勇,男,博士,副教授,药品、医疗器械警戒技术和方法研究。1993年7月毕业于北京医科大学药学院药化专业,获理学博士学位。先后在北京医科大学,北京大学医学部,成都市卫生局,国家食品药品监督管理局药品认证管理中心、机关服务中心、药品评价中心工作。现任国家药品监督管理局药品评价中心主任,《中国药物警戒》期刊主编。

Thoughts on constructing vigilance system of Chinese medical device in the new era

SHEN Chuanyong, SONG Yana, ZHAO Yan, ZHENG Lijia, ZHAO Yifei, LI Dong

Center for Drug Reevaluation, NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100022, China

Received:2022-03-11 Online:2022-07-15 Published:2022-07-12

摘要/Abstract

摘要： 目的通过分析我国医疗器械不良事件监测工作现状以及面临的机遇和挑战,提出新时代构建我国医疗器械警戒体系的思考。方法立足中国国情,结合我国医疗器械产业发展现状和深化审评审批制度带来的监管理念变革情况,通过查阅文献资料、对比分析等方法,对我国医疗器械上市后监测评价工作面临的机遇和挑战进行分析。结果结合国内外监管法规现状,提出加快完善医疗器械上市后监测评价体系、提高上市后医疗器械风险管控能力、构建我国医疗器械警戒体系的思路。结论以监管科学为引领,探索推动医疗器械警戒制度的建立,是新时期、新形势、新体制下医疗器械监管的重要课题。

关键词: 医疗器械上市后监测评价, 不良事件, 医疗器械警戒

Abstract: Objective To analyze the current status as well as the opportunities and challenges facing post-marketing surveillance and evaluation of medical devices in my country, this paper puts forward the thinking of constructing vigilance system of Chinese medical device in the new era. Methods Based on China's national conditions, combined with the development status of my country's medical device industry and the reform of medical device supervision concepts brought about by deepening the review and approval system, this article analyzes the opportunities and challenges facing post-marketing surveillance and evaluation of medical devices in China by reviewing literature, data comparison and other method. Results Combined with the current situation of domestic and foreign regulatory regulations, ideas are offered as to how to improve the regulatory system of surveillance and evaluation quickly, enhance the capabilities of risk control of post-marketing medical device products, and construct vigilance system of Chinese medical device. Conclusion Exploring and promoting the construction of medical device vigilance system is an important subject of medical device supervision in the new era, new situation and new system under the guidance of regulatory science.

Key words: post-marketing surveillance and evaluation of medical device, adverse event, medical device vigilance

中图分类号:

R994.11

沈传勇, 宋雅娜, 赵燕, 郑立佳, 赵一飞, 李栋. 新时代构建我国医疗器械警戒体系的思考[J]. 中国药物警戒, 2022, 19(7): 697-701.

SHEN Chuanyong, SONG Yana, ZHAO Yan, ZHENG Lijia, ZHAO Yifei, LI Dong. Thoughts on constructing vigilance system of Chinese medical device in the new era[J]. Chinese Journal of Pharmacovigilance, 2022, 19(7): 697-701.

参考文献

[1] The General Office of the CPC Central Committee and general office of the State Council. Opinions on deepening the reform of drug review and approval system and encouraging innovation in pharmaceutical products and medical apparatus [EB/OL]. (2017-10-08)[2022-01-06]. http://www.gov.cn/xinwen/2017-10/08/content_5230105.htm.
[2] GAO GB.Facilitating the clinical real world data research application in the hainan boao lecheng international medical tourism pilot zone through multi-dimentional innovation[J]. China Food & Drug Administration Magazine(中国食品药品监管), 2020, 202(11): 6-13.
[3] YU C, XU YM, LUO P, et al.Research on the quality evaluation system of medical device adverse event report based on improved delphi[J]. China Medical Device Information(中国医疗器械信息), 2021, 27(1): 11-12, 27.
[4] YANG Y.Research of regulatory science[J]. China Food & Drug Administration Magazine(中国食品药品监管), 2019, 183(4): 13-23.
[5] National Medical Products Administration. Opinions of the NMPA on further strengthening the adverse drug reaction monitoring system and capacity building[EB/OL]. (2020-07-28)[2022-01-06]. https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20200731134330152.html.
[6] National Medical Products Administration. Regulations on the supervision and administration of medical devices[EB/OL].(2021-03-19)[2021-03-20]. https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20210319202057136.html.
[7] National Medical Products Administration. The 14th five-year plan for national drug safety and promotion of high quality development [EB/OL]. (2020-12-30)[2022-01-06]. https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjzh/20211230192314164.html.
[8] MAO ZB, LIU SY.Implications of regulatory science for the construction of medical device vigilance systems[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2021, 18(7): 601-605, 619.
[9] Eammon Hoxey. Comparison of the articles of the european medical devices directive (93/42/EEC) andthemedical devices regulation ((EU) 2017/745)[EB/OL].[2022-01-06]. https://www.bsigroup.com.
[10] The European Parliament and the Council of the European Union.Medical device regulation(EU)2017/745[EB/OL].(2017-04-05)[2021-01-15].https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745.
[11] ZHAO Y, ZHAO YF, ZHENG LJ, et al.Medical device vigilance systems in european union[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2021, 18(6): 566-569.
[12] SHANG H, ZHANG SQ.Discussion of enlightenment from the reorga-nization of CDRH regulatory for medical device[J]. Chinese Journal of Medical lnstrumentation(中国医疗器械杂志), 2020, 44(2): 154-157.
[13] Xinhuanet. Decision of the CPC Central Committee on several major issues concerning upholding and improving the system of socialism with Chinese characteristics and modernizing China's system and capacity for governance[EB/OL]. (2019-11-05) [2022-01-06]. http://www.xinhuanet.com/politics/2019-11/05/c_1125195786.htm.
[14] NIU DS,XU S,LIU XD, et al.Analysis of key points and changes of the newly issued regulations for the supervision and administration of medical devices[J]. Modern Instruments & Mediccal Treatment(现代仪器与医疗), 2021, 27(4): 15-18.
[15] Central People's Government of the People's Republic of China. General Office of the State Council issues Implementation Opinions on Comprehensively Strengthening Drug Regulatory Capacity Building. (2021-05-10) [2022-01-06].http://www.gov.cn/xinwen/2021-05/10/content_5605647.htm.
[16] WANG X, YANG Y.Patient registry system and its application of supporting drugs and medical devices regulation[J]. Chinese Pharmaceutical Journal(中国药学杂志), 2021, 56(9): 762-769.
[17] YU Y, ZHEN W, LIN W, et al.Current status and analysis of overseas and domestic medical device registry study[J]. China Medical Device Information(中国医疗器械信息), 2021, 27(1): 1-3, 167.
[18] YANG Y, ZHAN SY.Analysis of necessity and feasibility in studies of post-marketing drug safety active surveillance based on big data[J]. Chinese Journal of Pharmacoepidemiology(药物流行病学杂志), 2016, 25(7): 401-404, 413.
[19] DING JJ, LIU B, GUO YJ.Discussions on the application of risk manage-ment in the performance evaluation of medical device[J]. Chinese Journal of Prosthodontics(口腔颌面修复学杂志), 2020, 21(3): 168-172.
[20] WANG LM.Investigation on the promotion of the medical device postmarket safety surveillance in China[J]. China Medical Device Information(中国医疗器械信息), 2009, 15(4): 48-52.
[21] LI QH, ZHU CC, CHEN C.Exploration on the early identification of medical risks in the application of medical safety management[J]. China Modern Medicine(中国当代医药), 2020, 27(23): 176-179.

新时代构建我国医疗器械警戒体系的思考

Thoughts on constructing vigilance system of Chinese medical device in the new era

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