Recently, the “Measurement of Medical Device Registrants & Private Hospital Institutions Class B Large-scale Equipment Approval Policy Interpretation Summit Forum” was held in Shanghai. The participants held a conference on the medical device registrant system that began in Shanghai Free Trade Zone in December 2017. A heated discussion was held and the development of the medical device industry in China was prospected.
According to Cheng Yunzhang, vice president of the School of Medical Devices and Foods at the University of Shanghai for Science and Technology, with the introduction of a series of favorable policies, China's medical device industry has developed rapidly and various industry indicators have steadily increased.
New Deal brings new impetus
All along, China’s medical device registration and production have been “bundled” and must be completed by one subject.This “bundled” model has affected the enthusiasm of the company’s innovative R&D and continuous improvement of product quality, and has also limited the rational allocation of innovative elements.
Zhang Feng, chairman of the Austrian-supported medical device service group, stated in this regard that, with the exception of the patent R&D time under the current system, China's second and third categories of medical device products will take 3 to 8 years from new product development to product launch. Time, investment needs 10 million to 100 million yuan.
”Zhou Yong, chairman of Guangyao Baiyunshan International Medical Device Innovation Park, also pointed out: "In the past, if researchers wanted to achieve the transformation of results, they must first open the factory as the owner."
For the system of medical device registrants piloted in the Shanghai Free Trade Zone, the participants considered that the introduction of the policy “unbundled” the registration and production of medical devices, fundamentally solved the problem of entrusted production, and listed innovative products. Accelerating quality has a positive impact on promoting the transformation and upgrading of the entire medical device industry and the development of the medical device industry.
“The new policy enables professional people to do professional things.” Shi Yonghui, director of investment of Medtronic China Medical Technology Fund, is very optimistic about the system of medical device registrants.However, he also reminded that there are still many professional barriers in the medical industry. Therefore, the implementation of the new policy needs to be run in and it must be solidly promoted. Especially early policy recipients need stronger partners.
Academician Dai Kejian of the Chinese Academy of Engineering stated that the system of medical device registrants provides convenience and motivation for the transformation of scientific research results, which will benefit the R&D of products for later improvement and continuous innovation.It reduces the R&D costs and risks of the research results to the entrusted party; at the same time, it also helps the regulatory authorities to continue to improve the registered production supervision system.
Industry usher in new life
According to Cheng Yunzhang, the compound growth rate of the Chinese medical device market from 2010 to 2017 was 19.9%.At present, the market size is approximately 448 billion yuan. According to the “Annual Report on Food and Drug Supervision and Statistics in 2017”, as of the end of November 2017, there were 16,000 medical device manufacturers nationwide, and a total of 410,000 medical device manufacturers of the second and third categories.
The “China Medical Device Industry Development Report (2017)” predicts that by 2020, the total annual sales of medical devices in China will exceed 700 billion yuan. In the next 10 years, the pace of development of China's medical device industry will continue to exceed 10% annually.
In this regard, some people in the industry believe that with the continuous deepening of medical reform, in the future, international medical device innovation cooperation will become a trend, such as opening up international channels, docking with foreign talent, projects, technologies, and fully carry out international exchange activities;By organizing domestic and international training in the vertical field, we will create top talent training platforms, cutting-edge technologies, and innovative cooperation platforms to promote domestic resources and international resources;Build an on-line platform talent pool, project library, expert database, and knowledge base to provide support services for international innovation cooperation.
Zhao Qun, a partner at Yuanhe, believes that there are huge market demands in the field of medical devices. There are funds for research and development, good companies for production, and good policies for escort. Therefore, the future of the medical device industry is very promising.
Chen Huawei, partner of Oriental Fuhai Investment Management Co., Ltd., also stated that it is now a good time to invest in the field of medical devices. The time cost and investment cost of the original new product are very large.However, with the introduction of various new policies, the cost of these aspects has been reduced, and it is very good for the start-up companies.
Cheng Yunzhang pointed out that from a policy perspective, the state encourages and supports grass-roots medical units to use excellent domestic medical equipment and device. Therefore, the domestically-made excellent medical equipment brand will usher in the grass-roots field.New technologies such as early screening technology, artificial intelligence, 3D printing, medical robots, etc., will also bring new vitality to the industry. At the same time, precision medical care has gradually evolved from concept to maturity, so the precision medical industry will also usher in a shuffle.
Cheng Yunzhang also said that home medical devices will also accelerate growth in the next few years. Especially with the development of wearable instruments.Diagnostic monitoring instruments represented by sphygmomanometers, stethoscopes, etc., and home medical devices that improve the quality of life of patients will usher in new flashpoints.