On November 6, the State Drug Administration issued the newly revised Special Review Procedure for Innovative Medical Devices, which came into effect on December 1, 2018. In order to further promote the reform of the examination and approval system, encourage innovation of medical devices, deepen the structural reform of supply side and “ release control clothing ” reform requirements, and encourage high-quality development of industrial innovation.
According to the data of "Research Report on Investment in China's Big Health Industry 2018-2020", since entering the 21st century, China's medical device industry has stepped into a high-speed growth stage as a whole, with the total sales volume increasing from 17.9 billion yuan in 2001 to 25.56 billion yuan in 2014, an increase of 1.428 times. From 2010 to 2016, the domestic medical device market grew from 126 billion yuan in 2010 to 370 billion yuan in 2016, with a compound annual growth rate of 19.67%. In 2017, the Chinese medical device market has exceeded 400 billion yuan.
Influenced by many basic factors, such as industrial upgrading, import substitution, demographic changes and medical reform, China's medical device industry has maintained a relatively rapid development rate, greatly surpassing the global growth of about 5% of the medical device industry. However, no matter the proportion of China's medical device industry in the world or the market value of listed companies, there is still a gap between China's medical device industry and the world's advanced level.
Dependence on imports
Although there are more than 2,000 export-certified enterprises in China, most of them are relatively weak in scale and brand competitiveness, and lack of core technology. OEM is the main form of export, lacking of their own brand, and they are generally at a disadvantage in the international market competition. From the perspective of China's medical device market, high-end products mainly rely on imports.
China is the second largest high-end medical equipment market in the world. For a long time, the highly technology-intensive equipment such as MRI, CT and PET-CT has been almost monopolized by GE, Philips and Siemens.
Relevant experts pointed out that there are three shortcomings in domestic medical device enterprises. Firstly, the strategy of low-price bidding for domestic brands. Lack of strategic positioning, lower than the standard of high-end products, with agents to synchronize the reduction of profits. Competition is at a disadvantage, there is not enough profit to continue research and development, lack of financial support, and upgrading is also facing technical and financial pressure, insufficient market brand investment.
Secondly, it is difficult for a single technological breakthrough to form a platform advantage. Lack of long-term technology portfolio, dilute customer development costs, afraid to invest in training and developing customers. Finally, there is a gap in technical details in the process of simple imitation. Similar in shape but different in spirit, resulting in uneven quality. The development of China's medical device industry is weak, the supervision of medical devices started late, and the phenomenon of small, large, scattered and low-level competition in medical device enterprises has not yet been fundamentally changed.
Technological breakthroughs
It has become a top priority to accelerate the improvement of technological innovation capability of China's medical device industry and to strengthen the joint production, learning and research of medical device research and development.
According to the statistics of China Medical Equipment, in 2016, General Electric ranked first in the market share of CT, MRI, ultrasound imaging and nuclear medicine, and Philips ranked first in the market share of angiography and general radiography. The three multinational companies, GPS, monopolize 70% of China's high-end medical equipment, while the proportion of domestic equipment is less than 10%. However, in some areas, domestic enterprises began to emerge. Myry Medical ranked first (58.0%) in guardianship products, Laokan and Xinhua Medical ranked first (41.4%) and second (17.8%) in disinfection equipment respectively.
The Blue Book of Medical Devices: China's Medical Devices Industry Development Report (2018) points out that in the next ten years, China's medical device industry has a bright future and the development of artificial intelligence medicine is in the ascendant. According to incomplete statistics, as of July 2017, there were 139 intelligent medical enterprises in China. Beijing, Shanghai, Shenzhen, Hangzhou, Wuhan and other technological innovation highlands have become the gathering places of intelligent medical enterprises (about 75%), especially in Beijing, which has reached 58. According to estimates, as of August 2017, the financing scale of China Medical Artificial Intelligence Company totaled more than 18 billion yuan, 106 industry enterprises realized financing.
The Blue Book emphasizes that the consistency between Chinese medical device standards and international standards has exceeded 90%. This has strongly promoted the development of China's medical device industry and created conditions for China's medical device to enter the international market.
The newly revised "Special Review Procedure for Innovative Medical Devices" will soon be implemented, which will also help to improve the efficiency of innovative medical device review and play a positive role in encouraging innovative development of the medical device industry. It has played an active role in promoting the innovation of medical device research and development, the popularization and application of new technology and the high-quality development of industry.