中国药业2025，Vol.34Issue(14)：1-7,7.DOI:10.3969/j.issn.1006-4931.2025.14.001
江苏省医疗器械生产企业信息化建设调研与对策研究
Investigation and Countermeasure Analysis of Informatization of Medical Device Intelligent Supervision Enterprises in Jiangsu Province
摘要
Abstract
Objective To investigate the current status of informatization development among medical device manufacturers in Jiangsu Province and propose targeted recommendations.Methods An online survey was conducted among 3 300 medical device manufacturers across 13 prefecture-level cities in Jiangsu Province.Data was collected on basic enterprise information,informatization infrastructure and scale,application of enterprise information systems,and demands regarding regulatory platforms.Results A total of 1 181 valid questionnaires were retrieved,the effective response rate was 35.79%.The majority of surveyed enterprises were located in Southern Jiangsu(782 enterprises,66.22%),followed by Central Jiangsu(213 enterprises,18.04%)and Northern Jiangsu(186 enterprises,15.75%).Most surveyed enterprises were privately owned(1 022 enterprises,86.54%),operated as registrants/filing entities(1 149 enterprises,97.29%),and primarily produced Class Ⅱ(830 enterprises,70.28%)and Class Ⅰ(733 enterprises,62.07%)medical devices.In 2022,the largest proportion of surveyed enterprises'operating income was less than CNY 200 million(816 enterprises,69.09%),36.92%of surveyed enterprises'net loss,and 48.94%of surveyed enterprises'net profit was CNY 0-0.05 billion;80.69%of surveyed enterprises had a total number of employees less than 100,60.71%did not use the unique instrument identification traceability,88.99%of the information technology department in surveyed enterprises team personnel≤5,67.99%of surveyed enterprises annual investment/operating income less than 0.1%,90.72%of the surveyed enterprises information technology department annual budget less than CNY 1 million,and 67.32%of the information technology department was technical support.The insufficient dedicated funding for informatization construction(34.29%)and the lack of technical talents(27.10%)were the main obstacles to the informatization construction of the surveyed enterprises.58.76%of surveyed enterprises were still mainly based on traditional information technology architecture,and had not yet implemented cloud computing systems,business intelligence systems,supply chain management systems,manufacturing execution systems,etc.More than 70%of surveyed enterprises did not have digital interfaces and automated production lines.The demands of the surveyed enterprises for the regulatory platform mainly focused on optimizing system functions and strengthening skills improvement,simplifying operational processes.Conclusion Insufficient funds for informatization construction,lack of professional and technical personnel,small industry scale,weak informatization foundation and inconsistent technical standards of supervision platform are the main problems faced by the informatization development of medical device manufacturers in Jiangsu Province.Through the following strategies to improve the level of information and intelligent supervision of related enterprises:establishing digital supervision strategies to optimize organizational structures,unifying technical standards for regulatory platforms to reduce communication costs,and improving regulatory policies to enhance informatization level.关键词
医疗器械生产企业/信息化建设/智慧监管/江苏省Key words
medical device intelligent supervision enterprises/informatization/intelligent supervision/Jiangsu Province分类
医药卫生引用本文复制引用
蒋漪,孙文明,梁毅..江苏省医疗器械生产企业信息化建设调研与对策研究[J].中国药业,2025,34(14):1-7,7.基金项目
中国药品监督管理研究会研究课题[2024-Y-Q-008]. （）
