Medical device approval reform deepening | Experts predict that industry leaders will appear in these areas
Medical Network July 4th Medical equipment is an important foundation for the construction of a health protection system. It is an important indicator of a country's scientific and technological progress and national health protection capabilities. In the past two years, the state has also attached great importance to the rapid and healthy development of the medical device industry. A number of policies to encourage and support the innovation and development of the medical device industry.
State Food and Drug Administration held on the 2nd medical instruments At the on-site investigation and evaluation meeting, Sun Lei, director of the Medical Device Technology Evaluation Center of the State Food and Drug Administration, said: 'Medical devices maintain a compound growth rate of more than 20% per year, higher than any other industry. In the health industry, the society in this field The investment is the most. The market space in the future is still very large. In general, the ratio of medicines to machinery in developing countries is 1:1. The ratio of medicines in China is only 1:0.4.
The China Medical Device Industry Development Report (2017) shows that by 2020, the total annual sales of medical devices in China is expected to exceed 700 billion yuan.
With the advancement of science and technology, especially the implementation of the policy of encouraging the development of innovative medical device production and the promotion of medical demand, China's independent innovation of medical devices will accelerate. In response to market demand, the National Medical Device Approval Center has carried out Comprehensive transformation of the approval system.
'Under the management service, we have optimized the review process, allowing people to run less and let the data run more. According to the product risk level and management category, rational allocation of resources, for innovative products, early intervention, special responsibility, in standard Under the premise of not reducing, the procedure is not reduced, for the innovative medical devices, priority approval projects will be given priority in the technical approval process. ' Sun Lei said.
In addition, according to the reform requirements of the review system, the Center simultaneously carried out the optimization and re-engineering and evaluation information system to meet the needs of the review work, and combined with the International Medical Device Regulatory Agency Forum (IMDRF) Registration Reporting Specification (RPS) to measure the work and International relevant registration electronic filing requirements, research and development of China's registered electronic submission (eRPS) application materials, format and coding requirements, establish a unified online reporting platform for medical device acceptance review and approval, and realize electronic submission and review and approval of medical device registration applications .
'Informatization means to connect online reservations with offline consultations to build a more efficient and smooth consultation and communication platform. Improve the website of the center, build the WeChat service number, highlight the characteristics of the review, and actively play in policy interpretation and consulting services. Review the role of dynamic query and other aspects. Currently in Shanghai, Guangzhou, Jiangsu, Zhejiang and other places opened a remote video expert review. 'Sun Lei said.
Since the establishment of the center, the number of medical device registrations has increased year by year, from less than 1,000 in 1997 to 1,500 in 2000, to 6,737 in 2008, and a record high in 2014, reaching 11,233. Over 10 years The number of registrations has increased by 10 times. 'Sun Lei said, 'Through the reform, China has realized the scientific approval of medical devices, improving efficiency, and at the same time. enterprise Through this system, the quality of research and development has been improved a lot, making the industry more health , will have greater competitiveness in the world. '
The deepening reform of medical device approval has further spurred the industry's innovation potential, but it will also bring about a wave of restructuring and consolidation shocks.
'Next year we will be on-line electronic filing system, will use higher management concepts to do medical equipment, and some companies may not dare to declare. At the same time, medical equipment mergers and reorganizations are more, will continue to annex SMEs. ' Sun Lei said.
At present, there are 15,343 medical device manufacturers in China, but half of the enterprises with output value below 20 million. Medical device reform will further aggravate the merger and reorganization of the medical device industry. Industry experts predict that the medical device industry in China will be in the next 5-10 years. The 'aircraft carrier' will probably be born in the Pearl River Delta, the Yangtze River Delta, or the Bohai Sea region.
