General Overview of Medical Device Industry
Release time:
2023-08-16
Medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials and other similar or related articles that are directly or indirectly used in the human body, including required computer software. The state of medical devices in accordance with the degree of risk classification management, a total of three categories: The first category is a low degree of risk, the implementation of routine management can ensure its safety and effectiveness of medical devices. Such medical devices are subject to product filing management. The second category is a medical device with moderate risk and requires strict control and management to ensure its safety and effectiveness. The third category is a high risk, need to take special measures to strictly control the management to ensure the safety and effectiveness of medical devices. Among them, the second and third types of medical devices are subject to product registration management. my country's medical device industry has not yet changed the situation of small and medium-sized enterprises. As of the end of 2019, there are 18000 medical device manufacturers in the country, including: 8232 companies that can produce first-class products, 10033 companies that can produce second-class products, and 1977 companies that can produce third-class products. The medical device industry market is large and segmented in many areas, superimposed on the post-epidemic period of primary medical institutions equipment upgrades, the market demand for various types of medical devices is growing steadily.
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