美国和欧盟标准化战略对我国医疗器械标准化工作的启示

Enlightenment of Standardization Strategies of the United States and European Union on the Standardization Work of Medical Devices in China

目的为我国医疗器械标准化战略的制订和实施提供新思路,助推我国医疗器械产业高质量发展。方法通过对比研究美国和欧盟标准化战略,了解其医疗器械标准化工作的现状及未来的宏观发展方向。总结我国医疗器械标准化工作发展历程,并就该领域发展提出建议。结果与结论美国标准化战略稳定性较强,且注重科技标准化;欧盟战略性和政治性更高,且与产业政策联系紧密;两者均是以国际标准化为核心的“控制国际标准型国际贸易战略”,关注标准的应用,重视标准化工作人才队伍建设。我国标准化工作起步晚、基础较薄弱,在其具体实施措施的制订和落实方面对产业高质量发展的规范性和引领性作用还不够。基于此,未来应强化医疗器械标准化战略的制订,以及医疗器械标准数字化建设和医疗器械标准化人才队伍建设。

Objective To provide new ideas for the formulation and implementation of China's medical device standardization strategies,and to promote the high-quality development of China's medical device industry.Methods The standardization strategies of the United States and European Union were compared to understand the current status of medical device standardization work and its future macroscopic development direction in both.The development process of medical device standardization work in China was summarized,and relevant suggestions for the development in this field were put forward.Results and Conclusion The standardization strategy in the United States has strong stability and emphasizes the technological standardization;that in European Union has a stronger strategic and political characteristics,and is closely related to the industrial policies.Both of the above strategies are the international trade strategies controlling the international standard with international standardization as a core,focus on the application of standards and the construction of talent teams in standardization work.The standardization work in our country started late and has a relatively weak foundation;in terms of the formulation and implementation of specific measures,its normative and leading role in the high-quality development of the industry is still insufficient.Based on this,we should strengthen the formulation of medical device standardization strategies in future,as well as the digitalization of medical device standards and the construction of talent teams in medical device standardization.