Coordination Mechanism Research Of The Construction Of The Standardization Of Medical Equipment In China

Medical devices are widely used for diseases prevention, diagnosis, treatment and rehabilitation. Medical device is an important part of disease diagnosis and treatment in modern medicine. The medical device industry covers materials, computer, mechanics, informatics, biology, medicine and many other advanced technologies. The medical device industry has become one of the emerging industries with the greatest growth potential and has been identified as a strategic industry by many countries. The rapid development of the medical device industry is based on medical device standardization. The importance of standardization in international competition and technical innovation has been recognized by many countries and industries. The standardization level of medical devices has become an important indicator of the modernization of the medical device industry.Standardization for medical devices is still underway in China. China still lacks systematic solutions, framework and management. The paper focuses on the current status of medical device standardization in China to reveal the dynamic mechanism for development of medical device standards based on the actor-network theory and improve the innovative and coordinative mechanism for medical device standardization.Based on literature review, expert consultation and comparative analysis, the paper analyzed the current status and strategies of medical device standardization in US, Europe, Japan and other developed countries and summarized valuable experience for China. Based on quantitative analysis of development and management of medical device standardization in China, the paper summarized China’s advantages, disadvantages and management experience. The paper also analyzed detailed activities of various actors in developing medical device standards and put forward corresponding recommendations. From the perspective of synthetics, the paper also established synthetic framework and analysis framework for medical device standardization and put forward suggestions on synthetizing knowledge and technologies for development of medical device standards. The synthetic model for medical device standardization will not only create a better environment to improve the competitiveness of China’s medical devices, but also provide reference to development of high-level international standards for medical devices.