1. Industry classification According to the “Guidelines for the Classification of Listed Companies in the Industry†(2012 Revision) issued by the China Securities Regulatory Commission, the industry in which the medical device business is located belongs to the “special equipment manufacturing industry†(C35) in the manufacturing industry. According to the National Standards for National Economic Industries (GB/T 4754-2011), the medical device industry is one of the branches of "Medical Diagnostics, Monitoring and Treatment Equipment Manufacturing" under the category of "Medical Instruments and Devices Manufacturing". Medical diagnostic equipment manufacturing. 2. Industry regulatory system, major laws, regulations and policies (1) Industry authorities and regulatory systems The competent departments of the medical device industry are the National Development and Reform Commission and the State Food and Drug Administration. The National Development and Reform Commission is responsible for organizing and implementing the pharmaceutical industry industrial policy, researching and formulating the development plan for the medical device industry, guiding the adjustment of the industry structure and implementing industry management; The State Food and Drug Administration is responsible for administrative supervision and technical management of the research, production, circulation and use of medical device companies. China Medical Device Industry Association and China Medical Equipment Association are internal management organizations of the industry. They are mainly responsible for conducting research and development of industry development issues, organizing and supervising the implementation of industry policies, and formulating industry development plans. (2) Major laws, regulations and policies of the industry The State Drug Administration Department has formulated and promulgated a series of laws and regulations governing the production of medical devices based on the Regulations on the Supervision and Administration of Medical Devices. The main regulatory regulations are as follows: Serial number file name main content 3. Overview of industry development (1) The global medical device industry continues to grow rapidly With the development of the economy, population growth, the aging of the society, and the growing awareness of people's health care, the global medical device market continues to grow rapidly, and the medical device industry is one of the fastest growing industries in the world. According to the statistics of the European Medical Device Committee, the total sales volume of the global medical device market has rapidly increased from US$210 billion in 2002 to US$469 billion in 2013, with a compound annual growth rate of 7.58%. The global medical device market growth rate exceeds the GDP over the same period. Increase. Source: EU Medical Device Council (2) The global medical device market has huge demand The medical device industry in developed countries and regions such as the United States, Europe and Japan has developed earlier, the domestic residents have a high standard of living, and the technical level and quality requirements for medical device products are relatively high. The market demand is mainly based on the upgrading of the latest products, and the market scale is huge. Demand growth is stable. Asian countries such as China and India, as well as Latin American countries such as Mexico and Brazil, and medical products in Russia and other Eastern European countries have developed rapidly. The demand for equipment popularization and upgrading has existed at the same time. The penetration rate of conventional medical electronic equipment has gradually increased rapidly. The market demand for medical electronic equipment products also maintained rapid growth. The medical electronic equipment market in Africa and other regions is still in the primary market. The product has a single function and the equipment penetration rate is less than 20%, but the growth potential is large. (3) China has become one of the global medical device manufacturing centers In the context of economic globalization, enterprises are increasingly eager to strengthen international cooperation and to allocate resources based on global resources. China has abundant resources, relatively low labor costs and huge market potential. Many medical device industry giants around the world set up subsidiaries in China or moved manufacturing and even R&D departments to China. In the process of competing with international enterprises, China's high-quality medical device enterprises have grown rapidly and gradually have the comprehensive strength and technical level to participate in international competition. Since the reform and opening up, China's medical device industry has developed rapidly. From 2009 to 2014, the overall scale of China's medical device manufacturing high-tech industry grew by 2.32 times, with a compound annual growth rate of 18.36%. Source: National Bureau of Statistics After 30 years of sustained high-speed development, China's medical device industry has initially established an industrial system with complete professional categories, perfect industrial chain and strong industrial base. It has also become the basic industry and leading industry of China's national economy. Tetanus Toxoid Vaccine,Toxoid Vaccine,Hep B Immune Globulin,Immunoglobulin Injections FOSHAN PHARMA CO., LTD. , https://www.forepharm.com
Depth: 2016 medical device industry research report