摘要
Abstract
Objective:In response to the rapid development of the medical device industry and the lag of traditional regulatory models,this study aims to construct an intelligent regulatory model based on"Internet Plus"technologies to enhance regulatory efficiency and ensure the safe use of medical devices.Methods:A combination of literature review,case analysis,and system modeling was adopted to analyze current challenges in medical device regulation.Drawing on advanced domestic and international experience,an overall architecture and functional framework for intelligent regulation was designed based on technologies such as cloud computing,big data,the Internet of Things(IoT),and artificial intelligence(AI).The feasibility and effectiveness of the model were examined through analysis of pilot practices in regions such as Zhejiang and Guangdong.Results:A three-layer architecture was developed,consisting of the regulatory side,the enterprise side,and data service platform.A regulatory system incorporating four core functional modules,registration and record-filing,distribution traceability,risk early warning,and emergency management,was established.Practical applications indicate that the Internet Plus–enabled intelligent regulatory model enables visualized management throughout the entire lifecycle,improves regulatory efficiency by over 60％,and achieves a risk identification accuracy rate of 85％,thereby significantly enhancing medical device safety assurance capabilities.Conclusion:The intelligent regulatory model empowered by"Internet Plus"represents an inevitable trend in the modernization of medical device regulation.By leveraging technological innovation to drive regulatory transformation,it can effectively address the limitations of traditional regulatory models and enhance the modernization of governance systems and capabilities.Future efforts should focus on improving standards and regulatory frameworks,strengthening cross-regional collaboration,and promoting the further development of intelligent regulation.关键词
医疗器械监管/互联网+/智能化/信息化平台/全生命周期管理Key words
medical device regulation/Internet Plus/intelligence/information platform/lifecycle management分类
医药卫生
