Medical Device Industry Classification

According to the latest "Regulations on the Supervision and Administration of Medical Devices" issued by the State Council in March 2021: Medical devices refer to instruments and equipment used directly or indirectly on the human body , instruments, in vitro diagnostic reagents and calibrators, materials and other similar or related items, including required computer software.

According to the structural characteristics of medical devices, medical devices can be divided into passive medical devices and active medical devices. According to whether they come into contact with the human body, medical devices can be divided into human body contact devices and non-human body contact devices. After combining the two classification methods, medical devices can be divided into passive human body contact devices, passive non-contact human body devices, active human body contact devices and active non-contact human body devices. The detailed classification is as follows:

Industry supply situation: The number of companies is on an upward trend

From 2006 to 2020, the number of domestic medical device manufacturing companies is on an upward trend. As of the end of 2020, there were 26,500 medical device manufacturers in the country, including 15,536 companies that can produce Class I products, 13,011 companies that can produce Class II products, and 2,181 companies that can produce Class III products.

According to the latest "Drug Supervision and Administration Statistical Report (Third Quarter of 2021)" released by the Food and Drug Administration in 2022, as of the third quarter of 2021, the number of manufacturing companies in China's medical device industry *** totaled 2.8 Wanjia, an increase of 5.62% compared with the end of 2020.

Current status of industry demand: market size is nearly one trillion yuan

——Medical and health institutions are steadily increasing

The downstream demand entities of China’s medical device industry are mainly various types of medical equipment Health institutions, including hospitals, primary medical and health institutions, professional public health institutions and other institutions.

According to statistics from the National Health Commission, the number of medical and health institutions in China has shown an upward trend from 2015 to 2021. As of November 2021, the overall number of medical and health institutions nationwide has reached 1.0436 million, a year-on-year increase of 2.02%.

——The production and sales situation of the industry is good

By calculating the production and sales rate of medical device products announced by each company in 2021, the average production and sales rate of representative enterprises in China's medical device industry in 2021 is 100.64% Among them, Mindray Medical and Zhende Medical's product sales and production rates are higher than the average. Although the average production and sales ratio of Libang Instruments, Yingke Medical, and Lepu Medical's products is lower than the average of the six representative companies, it still remains above 95%. This must be The degree reflects that the sales of products in the medical device industry are relatively good, and the backlog of goods inventory is not obvious.

——The market size will be nearly one trillion in 2021

In 2020, due to the sudden epidemic, China’s medical device market experienced a situation of “first decline and then rise”. From January to March, the domestic COVID-19 epidemic was rampant. The demand for low-value medical consumables related to the epidemic, such as medical masks, protective clothing, goggles, and disinfectants, increased significantly in the short term. Diagnostic reagents, life monitoring and support systems were in short supply, and domestic substitutes The call for imports is getting louder. The medical procurement process that requires precision medical equipment has collapsed, and elective surgeries are being canceled or postponed. The scale of the related high-value medical device market has declined in the short term. In the post-epidemic era, the non-anti-epidemic medical device market has recovered rapidly. Coupled with the structural changes in the population and the improvement of health awareness, my country's medical device industry as a whole has entered a stage of rapid growth.

According to statistics from the "China Medical Device Industry Blue Book (2021)", the market size of China's medical device industry has shown an increasing trend year by year from 2016 to 2021. In 2020, the market size of China's medical device industry reached 772.1 billion, a year-on-year increase of 21.76% . With the normal development of the epidemic in 2021, the demand for medical anti-epidemic materials has declined, causing the growth rate of the market size of China's medical device industry to also decline. According to preliminary statistics, the market size of China's medical device industry will reach nearly one trillion yuan in 2021, a year-on-year increase of 20.22 %.

——For more detailed research and analysis of this industry, please see the "Market Forecast and Investment Strategic Planning Analysis Report of China's Medical Device Industry" by the Qianzhan Industry Research Institute