Medical devices refer to instruments, equipment, instruments, in vitro diagnostic reagents and calibrators, materials, and other similar or related items directly or indirectly used in the human body, including required computer software. The country implements classified management of medical devices according to their degree of risk, which is divided into three categories:

The first type is medical devices with a low level of risk, and implementing routine management can ensure their safety and effectiveness. This type of medical device is subject to product registration management. The second type is a medical device with moderate risk that requires strict control and management to ensure its safety and effectiveness. The third category is medical devices that have high risks and require special measures to strictly control and manage them to ensure their safety and effectiveness. Among them, the second and third categories of medical devices are subject to product registration management.

At present, the medical device industry in China has not changed the situation of numerous small and medium-sized enterprises. As of the end of 2019, there were 18000 medical device production enterprises nationwide, 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 medical device industry has a large market scale and numerous segmented fields. Coupled with the upgrading of equipment in grassroots medical institutions during the post pandemic period, the market demand for various types of medical devices is steadily increasing.