Enlightenment of Standardization Strategies of the United States and European Union on the Standardization Work of Medical Devices in China
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.
the United StatesEuropean Unionstandardization strategymedical device
万方数据
维普
