Medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials and other similar or related articles directly or indirectly used for human body, including required computer software. According to the degree of risk, medical devices are classified into three categories
The first is the low-risk medical devices whose safety and effectiveness can be guaranteed by routine management. Such medical devices shall be subject to product record management. The second category is the medical devices with moderate risk, which need strict control and management to ensure their safety and effectiveness. The third category is the medical devices with high risks, which need to take special measures to strictly control and manage to ensure their safety and effectiveness. Among them, the second and third categories of medical devices are subject to product registration management.
At present, China's medical device industry has not changed the situation of numerous small and medium-sized enterprises. By the end of 2019, there are 18000 medical device manufacturers in China, including 8232 enterprises that can produce first-class products, 10033 enterprises that can produce second-class products, and 1977 enterprises that can produce third-class products.
The market scale of medical device industry is huge and there are many subdivisions. In the post epidemic period, the equipment of primary medical institutions is upgraded, and the market demand for all kinds of medical devices is growing steadily. A number of excellent enterprises have emerged in several major market segments in China, such as Mindray in the field of intensive care equipment and IVD, Neusoft in the field of imaging diagnosis, Weigao in the field of orthopedics, minimally invasive in the field of cardiovascular, Xinhua in the field of hospital equipment and drug delivery equipment, etc. Medical devices have a strong manufacturing attribute, and Chinese enterprises have many advantages, such as manufacturing cost, industrial supply chain supporting, engineer bonus and so on. China's medical device industry has gradually moved from imitation to independent innovation, and there is great potential for domestic substitution and overseas export breakthrough. In the future, it will face the global market.