文献计量分析视域下我国医疗器械政策与管理现状分析

Analysis of the current situation of medical device policy and management in China from the per-spective of bibliometric analysis

采用文献计量分析的方法统计年度发文量,利用知识可视化软件CiteSpace,分别从作者、发文机构、关键词等主题出发分析医疗器械政策与管理现状。结果显示,发文量在检索周期内(2009年至今)持续增长,2022年达到新高;前期研究主要围绕医疗器械行业标准化,后期监督管理方向的研究较多,研究团队以余新华等为代表,以中国食品药品检定研究院、国家食品药品监督管理总局医疗器械技术审评中心为主要研究单位;医疗器械研发投入、监管、政策支持属于研究热点话题。基于医疗器械政策与管理研究热点内容及发展脉络,建议继续强化产业政策支持力度,为医疗器械行业发展提供良好环境,刺激行业发展;需要持续加大产品研发投入力度,提升产品创新能力;继续完善监管体制,加快产业高质量发展。

The method of bibliometric analysis was used to calculate the annual number of publications,and the knowledge visualization software CiteSpace was used to analyze the current situation of medical de-vice policy and management from the themes of authors,publishing institutions and keywords.The re-sults showed that the number of publications continued to grow during the retrieval period(2009-present),reaching a new high in 2022;in the early stage,there were many research orientations around the stand-ardization of medical device industry,while in the later stage,the orientations mainly include supervision and management.The research team was represented by YU Xinhua and others,with the Chinese Acade-my of Food and Drug Control and the Medical Device Technical Evaluation Center of the State Food and Drug Administration as the main institutions;Medical device R&D investment,supervision and policy support were hot topics.Based on the research hotspots and development process of medical device policy and management,it is recommended to continue to strengthen industrial policy support,provide a good environment for the development of the medical device industry,and stimulate the development of the in-dustry.The medical device industry needs to strengthen the capability of product R&D investment and the product innovation,to improve the regulatory system and accelerate the high-quality development of the industry.