医疗器械检验检测现状及发展趋势探索  

Exploration of the Current Status and Development Trends of Medical Device Inspection and Testing

作　　者：周颖[1] 张敏燕[1] 王殊轶[1] 赵改平[1] ZHOU Ying;ZHANG Minyan;WANG Shuyi;ZHAO Gaiping(School of Health Science and Engineering,University of Shanghai for Science and Technology,Shanghai 200093,China)

机构地区：[1]上海理工大学健康科学与工程学院,上海200093

出　　处：《生物医学工程学进展》2024年第1期65-74,共10页Progress in Biomedical Engineering

基　　金：2021年上海交通大学中国质量发展研究院科研子课题《我国医疗器械检验检测发展现状与政策建议》;2023年度上海理工大学教师发展一般研究项目(CFTD2023YB32)。

摘　　要：目的该文旨在迎接我国医疗器械检验检测行业的新业态和新挑战,探索行业的未来发展方向。方法在概述医疗器械检验检测行业现状的基础上,采用专家访谈和线上问卷的方式,调研40家医疗器械检验检测机构及相关企事业单位,重点关注科技创新能力和形式、行业发展瓶颈等重要问题。结果通过整理和分析调研数据,得出行业发展的5个积极趋势:完善机构整体布局,加强区域特色中心建设;完善第三方合作研究组织和第三方评审机构的准入与监管机制;鼓励科技创新,优化人才队伍,赋能检验检测技术高质量发展;构建医疗器械安全监管信息化共享平台;加强在用医疗器械设备的安全监测。创新之处采用专家访谈和循证研究的方法,获取客观可靠的数据,为行业发展趋势的研究和探索提供了有力的依据。Objective This article aims to embrace the new formats and challenges in China’s medical device inspection and testing industry,and explore the future development direction of the industry.Methods Based on summarzing the current status of the inspection and testing industry of medical devices,through expert interviews and an online questionnaires,we surveyed 40 medical device inspection and testing institutions and related enterprises and institutions,focusing on important issues such as technological innovation capabilities and forms,and industry development bottlenecks.Results Through analysis and organization of the survey data,we have predicted five major industry development trends:improving overall organizational layout and planning and establishing regionally distinctive centers;enhancing access and regulatory mechanisms for third-party cooperative research organizations and third-party review institutions;promoting technological innovation and optimizing talent teams,enabling high quality development for inspection and testing technology;building a shared platform for medical device safety regulation information;and strengthening detection and safety monitoring of in-use medical equipment.Innovation The innovation of this article lies in the utilization of expert interviews and evidence-based research methods,obtaining objective and reliable data,and providing substantial evidence for the study and exploration of industry development trends.

关 键 词：检验检测 问卷调研 科技创新 发展趋势 

分 类 号：R197.39[医药卫生—卫生事业管理] R318[医药卫生—公共卫生与预防医学] F203[经济管理—国民经济]