监管法规协调背景下医疗器械国际标准转化研究与思考

目的：我国医疗器械产业蓬勃发展，医疗器械国际竞争力持续提高，国际医疗器械监管法规协调进程不断发展，科学合理转化国际标准，持续提升我国医疗器械标准与国际标准的一致性程度，进一步推进我国医疗器械标准与国际接轨，是提高我国医疗器械监管国际化水平的重要内容，对促进医疗器械国际贸易、提高医疗器械质量和技术水平，助力医疗器械科学监管具有重要的意义。方法：通过对我国医疗器械转化国际标准工作的回顾性研究，系统分析了医疗器械转化国际标准工作的现状、未转化国际标准的原因及存在的问题, 提出了促进我国医疗器械标准化工作高质量发展的机制和措施。结果与结论：研究提出了加强国际标准转化的政策引领，探索国际标准转化的机制创新，继续强化国际标准的跟踪、比对研究，加强监督考核和人才建设的具体措施，将有利于进一步提升我国医疗器械标准与国际标准的一致性程度，推动我国医疗器械标准化工作高质量发展。

On the Transformation of International Standards for Medical Devices in the Context of Regulatory Harmonization

Objective: The medical device industry in China has been developing vigorously, the international competitiveness of medical devices has been improved, and the coordination process of international medical device regulations continues to be promoted. Hence, continuously improving the consistency between Chinese medical device standards and international standards, and further promoting Chinese medical device standards to be in line with international standards are important for elevating the internationalization level of Chinese medical device regulation. It is of great signifi cance to promote the international trade of medical devices, improve the quality and technical level of medical devices, and help scientific supervision of medical devices. Methods: Through the retrospective study of the international standard of medical device transformation in China, this article systematically analyzed the current situation, the reasons and existing problems of the international standard of medical device transformation, and put forward the mechanism and measures to promote the high quality development of the standardization of medical devices in China. Results and Conclusion: This research puts forward specifi c measures to strengthen the transformation of international standard policy leading, explore the mechanism innovation of transformation of international standard. We should continue to strengthen the tracking and comparison of international standards, strengthen the supervision and assessment and personnel development of specifi c measures, which will be conducive to further improve the degree of consistency between Chinese medical device standards and international standards, and promote the high-quality development of Chinese medical device standardization.