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Since the reform and opening up, the development of China's medical device industry has attracted the attention of the world, especially since the beginning of the 21st century, the industry as a whole has entered a stage of rapid growth. The number of medical institutions across the country has grown steadily in the past five years, and a large amount of medical infrastructure investment will be brought about in the next few years, which will benefit medical device manufacturers. Starting in 2014, the first responsibility of medical device manufacturers will be further implemented, and the quality and safety awareness and level of manufacturers will be significantly improved, thereby promoting the structural adjustment and industrial upgrading of the medical device industry, and enhancing my country's medical device quality and safety assurance capabilities .

1. The development of my country's medical device industry

At present, my country's medical device market is growing rapidly, and it has become the world's third largest medical device market after the United States and Japan. my country has become a major area driving the increase in the global market. In the next few years, if the current rate of development is maintained, my country will surpass Japan to become the world's second largest medical device market. Medical devices and drugs are two important means of medical treatment. The sales ratios of the two in developed countries are relatively close, while the sales of medical devices in my country are about one-third of the sales of drugs, which shows that my country's medical device market has huge potential. The active medical device market in my country, the guidance of national policies and the demand for replacement of equipment in domestic medical and health institutions have made China a huge medical device consumer market. In the context of market demand stimulus and the sustained and stable development of China's economy, my country's medical device industry has developed rapidly. The important position in the entire pharmaceutical industry is becoming more and more prominent, and it is following the development path of "heavy equipment and light drugs" in developed countries. Of course, this still has a long way to go.

According to the Ministry of Industry and Information Technology, the output value of medical devices nationwide was 139.86 billion yuan in 2012; according to the China Medical Device Industry Association, the output value exceeded 300 billion yuan. According to conservative estimates, the output value of medical devices will reach 450-500 billion yuan by 2015.

According to the statistics of the State Food and Drug Administration, as of the end of 2012, there were 15,348 manufacturing enterprises (4370 in the first category, 8414 in the second category, and 2,564 in the third category). Among them, there are 829 key state-supervised enterprises and 1,175 key provincial-supervised enterprises. Generally speaking, the development of my country's medical device industry presents the following characteristics:

1. The regional development trend is good

With the development of my country's medical device industry, several medical device industry clusters and manufacturing development belts have been formed across the country. The Pearl River Delta, the Yangtze River Delta and the Beijing-Tianjin Bohai Bay have become the three major local medical device industry clusters. According to incomplete statistics, the sum of the total output value and the sum of sales of medical equipment in the three major regions accounted for more than 80% of the national total. Because of their different conditions, these three major industrial clusters have shown obvious regional characteristics.

In the Pearl River Delta (including Zhuhai, Guangzhou, etc.) centered on Shenzhen, the R&D and production of comprehensive high-tech medical equipment products are its strengths. The main products are medical imaging equipment such as monitoring equipment, ultrasound diagnosis, MRI, and gamma knife and X knife. And other large-scale stereotactic radiotherapy equipment, tumor hyperthermia equipment, etc., directly reflect the new technology of modern medical equipment. Shenzhen's export of medical equipment has developed rapidly, and the regional gross output value has increased at a rate of more than 30%. Shenzhen’s industrial advantages lie in the fields of electronics, computers, communications, and mechatronics. The development of modern medical equipment has integrated high-tech achievements in these fields, resulting in intensive advantages, plus Shenzhen’s preferential policies, mechanisms, The incentives and cultivation of market and other factors have enabled the medical device industry to flourish in Shenzhen.

In recent years, medical equipment in the Bohai Bay area (including Tianjin, Liaoning, and Shandong) centered on Beijing has developed rapidly. One includes DR, MRI, digital ultrasound, accelerator, computer navigation and positioning medical equipment, respiratory anesthesia machine, orthopedic equipment, and A group of manufacturers of cardiovascular equipment is taking shape. A number of small and medium-sized enterprises have risen rapidly. These enterprises have only been established within a few years, but their output value has approached or even exceeded 100 million yuan. With the help of the government's attention and their own scientific and technological capabilities, they are more inclined to the field of digital medical equipment. Although the power shown in the market is not very prominent and strong, but the momentum is strong and the potential is huge.

Shanghai has a solid industrial foundation. Whether it is products or technology, Shanghai is a leader in my country's medical device industry. The Yangtze River Delta (including Jiangsu and Zhejiang) with Shanghai as the center is one of the three major medical equipment industry clusters in my country. This area is characterized by rapid industrial development, active small and medium-sized enterprises, and obvious regional characteristics. Its disposable medical equipment and consumables The domestic market share of more than half. In addition, there are ophthalmic equipment in Suzhou, medical ultrasound in Wuxi, microwave in Nanjing, radiofrequency tumor hyperthermia, MRI in Ningbo, and Shanghai's comprehensive strength, which are relatively outstanding.

In addition, the Chengdu-Chongqing area with Chongqing as the center and the Central China area with Wuhan as the center are also emerging areas featuring biomedical materials, implantable devices, and tissue engineering.

2. The trade is in surplus, but the growth rate of imports is obviously stronger than that of exports

The slowdown in China's economic growth in 2013 is a change in the growth model brought about by the current economic transformation and upgrading and structural adjustment. Although the growth rate is lower than the previous double digits, this growth is moving towards a more balanced, higher quality and longer-lasting trend, so it is even more important. This is reflected in the fact that my country’s medical equipment trade situation in 2013 was that imports were significantly stronger than exports. This is inseparable from the current differentiation trend of various economies in the world. For example, developed economies have moderate employment but limited economic growth, and emerging economies are subject to inflationary pressure and economic growth. Difficulties and constraints such as rapid slowdown have led to a decline in the overall demand for medical devices in the global economy, which has a certain impact on my country’s foreign trade of medical devices.

China's foreign trade of medical devices in 2013:

According to China Customs data, in 2013, my country’s total medical device trade amounted to US$34.31 billion, a year-on-year increase of 14.13%, an increase of 1 percentage point over the previous year; of which, the export value was US$19.335 billion, a year-on-year increase of 9.92%, a decrease of 2 percentage points over the previous year. The import value was US$14.975 billion, a year-on-year increase of 20.07%, an increase of 5.5% over the previous year; the trade surplus was US$4.36 billion, a year-on-year decrease of 14.8%.

3. Increased R&D investment

my country's medical device industry has basically formed a multidisciplinary research and development system. my country has begun to enter a new stage of developing from mid-range products to high-end products, from small to large, and from weak to strong. However, the core technology of high-end products is basically controlled by large foreign companies. At present, the country has increased its investment in medical device research and development. Only when the domestic medical device industry establishes an enterprise-based, market-oriented, technological innovation system that combines production, learning, research, and application, fully integrates social resources, and uses group advantages to drive industrial development, can it be better able to become a global player. Close to the level, get faster development.

4. The overall level of the industry is at a lower-middle level in the world

The innovation ability of my country's medical device companies has increased, but the ability of technological innovation and achievement transformation is weak. Key parts and components rely on imports, and high-end products still focus on imitation and improvement. The market potential of our country is huge, and scientific and engineering research in some fields has reached the international advanced level. Furthermore, the world's leading medical device industry has only started for more than 10 years, and my country has great hopes to approach and catch up with the international level.

5. Foreign brands and joint venture brands have an advantage in the high-end market

The high-end medical equipment market is still monopolized by developed countries. The current high-end products on the market, such as CT, MRI and other high-end medical imaging products, still come from a few developed countries such as the United States and Japan. They have advanced technology and are leaders in the development of the global medical device industry.