中国药业2026，Vol.35Issue(12)：7-12,6.DOI:10.3969/j.issn.1006-4931.2026.12.002
成都市医疗器械智慧监管平台建设现状与需求分析
Analysis of the Current Status and Needs of the Construction of Chengdu Medical Device Intelligent Supervision Platform
摘要
Abstract
Objective To investigate the effectiveness,problems,and needs of the Chengdu Medical Device Intelligent Supervision Platform in practical application,and to provide theoretical references for the construction and development of the platform.Methods Using the procedural grounded theory paradigm,one-on-one semi-structured in-depth interviews were conducted with six regulatory personnel from Chengdu municipal and county-level medical device supervision departments and 9 employees from manufacturing/distribution enterprises.The interview texts were analyzed using Nvivo 12 Plus software through three levels of coding:open coding,axial coding,and selective coding,to extract core categories and construct a functional mechanism model.Results A total of 96 initial concepts,26 open coding categories,12 main categories,and four core categories were finally extracted.Interviewees'perceptions of intelligent supervision were concentrated on three aspects:network digitization,intelligent assisted regulatory decision-making,and operational convenience and efficiency improvement.Among them,regulatory personnel paid more attention to network technology applications,while enterprise employees focused more on operational convenience.Regarding the current status of platform use,regulatory personnel mainly used it for regulatory task management;enterprise employees mainly used it for filing,licensing,and training guidance.Platform advantages included improved efficiency and convenience,data management and transparency,self-service,and regulatory support training.Among influencing factors,the driving factors were mainly government-enterprise collaboration and user experience and convenience;the hindering factors were mainly insufficient platform integration(disconnected multi-level platform data,poor data exchange across systems)and poor user experience(some enterprises still preferred offline processing).Platform improvement goals focused on functional enhancement(intelligent generation of inspection forms,adding enterprise credit evaluation and risk early warning),user interaction optimization(adding online guidance windows and training content),and innovation in government-enterprise collaboration mechanisms(balancing information collection and privacy protection).Conclusion The intelligent supervision platform needs to establish core functional modules including data integration and management,intelligent risk warning,government-enterprise service integration,and regulatory decision support system.On this basis,system construction should be continuously improved from three dimensions:user interaction optimization,platform ecosystem integration,and innovation in government-enterprise collaboration mechanisms.关键词
医疗器械智慧监管平台/扎根理论/半结构化访谈/功能架构模型Key words
Medical Device Intelligent Supervision Platform/grounded theory/semi-structured interview/functional architecture model分类
医药卫生引用本文复制引用
黄薇,赵智淏,杨男,刘洋,洪肇鸿,周箬菲,黄真,胡明..成都市医疗器械智慧监管平台建设现状与需求分析[J].中国药业,2026,35(12):7-12,6.基金项目
中国药品监督管理研究会课题[2023-Y-Q-010,23H0384] （）
四川省成都市市场监督管理局医疗器械智慧监管风险预警应用研究项目[24H0966]. （）
