医疗器械检验发展情况分析与思考  

Analysis and Reflection on the Development of Medical Device Testing

作　　者：杨婉娟[1] 李静莉[1] 陈鸿波[1] Yang Wanjuan;Li Jingli;Chen Hongbo(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国药事》2025年第4期370-374,共5页Chinese Pharmaceutical Affairs

摘　　要：目的:通过对我国医疗器械检验发展历程进行梳理,分析检验现状及存在问题,为在《中华人民共和国医疗器械管理法》框架下进一步推动检验发展提供参考。方法:梳理国内外医疗器械检验发展历程,归纳《医疗器械监督管理条例》修订后检验形势和要求的变化,分析现阶段检验发展、面临挑战及存在问题。结果:《医疗器械监督管理条例》修订后,检验市场进一步活化,检验能力持续提升,为产业高速发展和科学监管提供了支撑,但也存在风险管理意识不足、检验规范性不足和能力参差不齐等问题。结论:应以《医疗器械管理法》及配套法规制定为契机,进一步完善法规引领和技术支撑,强化企业风险管理意识,加快规范检验市场行为,系统提升医疗器械检验能力建设。Objective:To analyze the current testing situation and existing problems by reviewing thedevelopment process of medical device testing in China,and to provide references for further promotingthe development of testing under the framework of the Medical Device Administration Law.Methods:Thedevelopment process of medical device testing at the domestic and international situation was reviewed,the changes in testing situations and requirements after the revision of the Medical Device Supervision andAdministration Regulations were summarized,and the current development,challenges and existing problemsof testing were analyzed.Results:After the revision of the Medical Device Supervision and AdministrationRegulations,the testing market had been further activated,and the testing capacity had continued to improve,providing support for the rapid development of the industry and scientific supervision.However,there werestill problems such as insufficient risk management awareness,insufficient standardization of testing,anduneven capacity.Conclusion:The formulation of the Medical Device Administration Law and its supportingregulations should be used as an opportunity to further improve the regulatory guidance and technical support,strengthen the risk management awareness of enterprises,accelerate the standardization of testing marketbehavior,and systematically enhance the construction of medical device testing capacity.

关 键 词：医疗器械检验 医疗器械监督管理条例 医疗器械管理法 风险管理 检验能力 

分 类 号：R95[医药卫生—药学]