Ten trends of medical device industry in China in the near future

In recent years, the innovation and development of domestic medical devices have been accelerating. On the one hand, accelerating the development and progress of medical devices will not only help to improve the innovation ability of medical devices in China, but also help to accelerate the overall level of the medical industry in China. The editor made an inventory of some important recent developments in the medical device industry in China for the readers!

The 2015 blue book on the development of China's medical device industry shows that the market potential of China's medical device industry is huge. In 2015, the sales scale of medical devices in China was about 308 billion yuan, an increase of about 18 times in 15 years. In 2015, the ratio of drug and equipment consumption was 1:0.33, far lower than the world average of 1:0.7, and even lower than the level of 1.02:1 in developed countries. To this end, the national policy continues to promote the research and development of domestic medical devices. In recent years, the innovation and development of domestic medical devices have been accelerating. On the one hand, accelerating the development and progress of medical devices will not only help to improve the innovation ability of medical devices in China, but also help to accelerate the overall level of the medical industry in China. The editor made an inventory of some important recent developments in the medical device industry in China for the readers!

PGD / PGs becomes the next innovation explosion point of medical devices for second generation sequencing

PGD / PGs is a detection technology for single gene genetic diseases and chromosome structure and number abnormalities, which has been recognized more and more clinically. This year, the state has successively publicized PGs products that have obtained special approval for innovative medical devices, and classified PGs as the third type of medical devices for supervision and management, which means that PGs has gradually entered the industrial application.

The State encourages the research and innovation of medical devices, plays the role of market mechanism, promotes the promotion and application of new technologies of medical devices, and promotes the development of medical device industry. The action mechanism of the product applying for innovative medical devices should be the first in China, the product performance or safety should be fundamentally improved compared with similar products, the technology should be at the international leading level, and have significant clinical application value.

PGs is an early prenatal screening method to improve the implantation rate and live rate of test tube infants, which is of great significance to avoid repeated abortion, reduce the birth of genetic children and clinical in vitro assisted reproduction. With the development and application of technology, the clinical application value of PGs is more and more obvious, and the market demand is also expanding. Special approval for innovative medical devices is the only way for the industrialization of PGs, and also the main regulatory process of the state for PGs industry. In the future, PGs products entering the clinic must meet the regulatory standards of the state, and products without medical device registration certificate will be difficult to enter the market.

Support domestic medical devices! Heilongjiang, Hunan and Hebei have taken action

According to statistics, as of the end of November 2015, there are 14151 medical device enterprises in China, which are still small and scattered. At present, less than 20% of the medical equipment enterprises are truly large-scale and have an output value of more than 20 million yuan. Medical devices are divided into 43 categories and tens of thousands of varieties. From the perspective of high-end medical diagnosis equipment market, especially in the top three hospitals in the first and second tier cities, the proportion of foreign investment is very high. Foreign investment accounts for more than 90% of the country's high-end medical diagnostic equipment.

In recent years, in order to break the situation that foreign medical equipment enterprises such as "GPS" (General Electric, Philips and Siemens) occupy the leading position in the Chinese market, many departments of the state have released signals to speed up the localization process of medical equipment, and successively issued many policies to support domestic medical equipment.

National clear: 5 categories and 26 categories of medical devices will focus on Development

Recently, the national development and Reform Commission issued the division plan for key departments of Guiding Opinions on promoting the healthy development of the pharmaceutical industry. Specifically to the medical device industry, 5 categories and 26 categories of medical devices will accelerate the transformation and upgrading, and become the focus of future national support and development.

In addition to the key tasks, the plan puts forward six policy guarantee measures, including: To study and develop the product catalog of innovation and excellent medical devices by the end of 2017; to formulate and improve the medical device allocation standards of medical institutions at all levels by the end of 2017; to promote the completion of the standardization of high-value medical consumables procurement code by the end of 2016, etc.

Guangyao holding hands with Meishi domestic high-end medical equipment in spring?

Recently, Baiyunshan Guangyao and Meishi medical Holding Co., Ltd. (hereinafter referred to as Meishi medical) officially signed a letter of intent for cooperation. The two sides plan to establish a joint venture company with an investment of about 300 million yuan to jointly build a high-end medical device R & D and production base with independent intellectual property rights in Guangzhou Development Zone.

Baiyunshan Guangyao, which was only engaged in the wholesale, sales and import and export of medical devices, officially entered the field of medical device R & D and production.

Strengthen the market supervision in the field of circulation and focus on rectifying the outstanding problems of medical devices

Recently, the food and Drug Administration of Yan'an City held a special meeting to hold a centralized interview with the heads of the relevant medical device business enterprises in the city, clearly informed the work content and key points of this rectification, and signed a letter of commitment for good faith operation with the heads of the enterprises, which strengthened the main responsibility of the enterprises.

It is reported that, according to the unified arrangement of the whole city, this centralized renovation will cover all the enterprises engaged in the second and third categories of medical devices in the whole city, focusing on the renovation of the wholesale business of medical devices sold to the unqualified business enterprises or users; the business conditions have changed and no longer meet the requirements of the medical device business quality management standards; the management of medical devices fails to comply with the regulations There are 8 illegal operations, such as the instructions of the medical devices that have been rectified and operated; the labels do not conform to the relevant regulations; the transportation and storage of the medical devices are not in accordance with the instructions of the medical devices and the labeling requirements.

The trend of "import substitution" of medical devices

In the field of high-end medical devices, 90% of the market share has been monopolized by foreign enterprises for a long time, and most domestic enterprises can only linger in the middle and low-end market for food. This situation is gradually being broken.

From July 8 to 9, 2016 kantley? 9th China (International) medical consumables Conference (mcc2016) and China Medical Devices Cooperation Forum jointly sponsored by China Chamber of Commerce for the import and export of medical and health products, China Medical Materials Association and China Medical News and Information Association opened in Zhuhai. Xu Ming, vice president of China Medical Insurance chamber of Commerce, said that "import substitution" in the medical device industry is the general trend, domestic enterprises have more opportunities than challenges, and the future market development prospect is broad.

Domestic brands in orthopedic medical device market dominated by imported instruments are ready to break through

The domestic orthopedic medical device market is growing rapidly, with a compound annual growth rate of 18%. Among them, the share of trauma, spine and joint orthopedic implants in the whole orthopedic medical device market is more than 80%. The latter two have high technical barriers, and foreign brands have the best advantage. However, in the past two years, the national level has successively introduced policies to try to reverse this situation, and large domestic orthopaedic manufacturers are expected to take this opportunity to expand domestic market share.

In terms of policies, the orthopedic medical device industry is a key encouraged industry supported by the state. Many policies, such as the 12th Five Year Plan of medical device technology industry turning to industrial planning, list orthopedic implants such as bone repair materials, artificial joints and spine as national key development products.

Medical device industry has gradually become the pillar industry in China

With the acceleration of China's aging society, the medical device industry has gradually become the pillar industry in China. In the surging wave of competition, many enterprises try to make their own products stand out in the medical device industry through industrial design.

Medical device industry is a multi-disciplinary, knowledge intensive, capital intensive high-tech industry, so it is regarded as one of the national comprehensive strength standards. With the support of national policies and the promotion of global competition, the field of medical devices in China has developed rapidly. In recent years, with the rapid development of China's medical device industry, the number of enterprises with production qualification has increased year by year. In 2016, as the first year of the 13th five year plan, the "spring" of medical device development is coming.

Chongqing's first innovative medical device incubation platform built

On April 26, Chongqing's first innovative medical device professional incubation platform was built in Hechuan, which will help the scientific research achievements of medical devices with independent intellectual property rights to be transformed rapidly in the future. According to reports, the incubation platform is constructed and operated by Chongqing zhihekang Medical Equipment Co., Ltd. (hereinafter referred to as zhihekang). Unlike many incubators that only provide office space and basic services, zhihekang has invested nearly 10 million yuan to build the production facilities of incubation platform, and now has built 100000 level GMP clean workshop, testing laboratory and ethylene oxide sterilization workshop with the production conditions for producing class I, II and III medical devices.

According to the introduction, for immature patent achievements, the incubation platform will first conduct analysis and demonstration, and then jointly develop a prototype or sample with the R & D team after the project is approved, carry out clinical verification and product registration certificate application, and then provide technology by the incubation platform to form a complete product production line and establish a production base for large-scale production. If it is a mature patent project, the incubation platform will also provide the R & D team with production facilities after analysis, demonstration and project approval, so as to realize mass production of products and help products enter the market smoothly.

Zhejiang Province vigorously promotes the development of medical device industry

Recently, the first working meeting of Zhejiang medical device industry development coordination group was held, and Cao Xin'an, deputy director of science and Technology Department of Zhejiang Province, presided over the meeting and delivered a speech.

At the meeting, the coordination group and office plan for the development of medical device industry in Zhejiang Province were reviewed, and the implementation of opinions on "precise docking and precise service" to support the improvement and development of medical device industry "issued by the general office of Zhejiang provincial government and the next work plan were heard. It is understood that in recent years, Zhejiang Province has listed two major industries, health and high-end equipment manufacturing, which are involved in the medical device industry, into the seven trillion level industries to be built. Up to now, there are more than 1300 medical device manufacturers in Zhejiang Province, ranking the fourth in China; in 2013, the sales revenue of medical device manufacturers above Designated Size in Zhejiang Province was 13.9 billion yuan, ranking the sixth in China.

Edit summary

According to the consumption ratio of Chinese medicine and equipment, China is only one fifth of the developed countries. It can be seen that the development prospect of this market is very broad, and the market is far from saturated. At the same time, in the top three hospitals in China, the proportion of foreign medical devices is very high. Therefore, it is of epoch-making significance to speed up the pace of medical device innovation in China and improve the level of large-scale medical device innovation.