新形势下医疗器械标准化体系研究

目的：研究在新形势下如何不断完善、构建更好的服务于监管需要和产业发展的医疗器械标准化体系。方法：通过对医疗器械标准化工作面临的新形势、新要求进行分析，从标准管理法规建设、组织架构建设、标准体系建设的角度对医疗器械标准化体系进行研究。结果与结论：通过持续深化标准化工作改革，继续强化医疗器械标准化顶层设计，探索研究医疗器械团体标准管理模式，深入推进医疗器械强制性标准整合、精简工作，从而建立适应新形势、更加科学合理、先进适用、开放兼容、规模适度的医疗器械标准化体系。

Study on the Medical Device Standardization System under the New Situation

Objective: To study how to improve and build a better medical device standardization system in order to serve the need of regualtion and industrial development under the new situation. Methods: The new situation and new requirements of the medical device standardization were analyzed. The medical device standardization system was studied from the following aspects: draft of standard management regulations, establishment of organization structure and construction of a standard system.Results and Conclusion: A more scientific and rational, advanced and applicable, open and compatible as well as appropriate-scaled medical device standardization system that adapts to new situation will be established by continuously deepening the reform of standardization, successively enhancing the top-level design of medical device standardization, exploring the management model of group standards for medical devices and further promoting the integration and simplification of mandatory standards for medical devices.