国家医疗器械质量监督抽验管理工作回顾及展望

Retrospect and Prospect of the National Sampling and Testing Management for Medical Device

目的:探讨我国医疗器械质量监督抽验管理模式。方法:从抽验远景规划升级、项目规模升级、法规支撑体系升级、组织运作模式升级、产品质量评估模式升级5个方面,回顾了近4年国家医疗器械质量监督抽验管理工作的总体情况;从继续探索更为科学的抽验模式和机制、继续优化抽验运作流程中的有关环节、继续发掘抽验数据的技术支撑作用3个方面进行了展望。结果与结论:我国医疗器械抽验特别是较大规模的抽验工作起步较晚,尚缺乏总体规划,工作基础比较薄弱,抽验工作在科学性、权威性等方面还存在不足,在思想认识、机制模式、能力保障等方面还有待进一步提高。希望本研究能为我国医疗器械质量监督抽验的发展提供一定的借鉴。

Objective： To explore the management mode of national sampling and testing for medical device in China. Methods： Firstly, this article reviewed the management of national sampling and testing for medical device in the last four years from the following five upgrading aspects： far-seeing plan, project size, laws and regulations system, management and operation manners, quality assessment manners for testing products. Secondly, this article proposed the future management of national sampling and testing for medical device from three aspects： continuing to explore more scientific manner and mechanism, to optimize the operation of relevant processes of national sampling and testing, to explore the technical benefits of the data from national sampling and testing for medical device. Results and Conclusion： Medical device sampling in China starts relatively late, especially in the large-scale sampling, overall planning is poor, and the basis of work is relatively weak. The sampling work in scientific, authoritative and other aspects need to be improved, as well as the ideological understanding, mechanism model, capacity protection and so on. It is hoped that this study will provide some references for the development of medical device quality supervision and testing in China.