Wearable medical devices will achieve new breakthroughs in the field of medical devices

Wearable medical devices will achieve new breakthroughs in the field of medical devices

On September 10, 2016, Xinhua News Agency "Financial Weekly", Xinhua News Agency think tank and Suzhou Bio-Nano Science and Technology Park held the "2016 (sixth) China Medical Device Summit Forum" in Suzhou, the State Food and Drug Administration. Gao Guozhen, deputy director of the registration management, attended and delivered a speech.

Gao Guozhen said that medical technology, medicines and medical devices are three parts of medical services. Medical devices are an important factor in promoting the health industry, influencing the reform of the medical system and the future medical reform trend. The establishment of the regulatory system for the development of the pharmaceutical industry is becoming more and more An important part of the national security system strategy and international trade negotiations.

According to the China Health Industry Blue Book published by China Medical Information in 2016, the medical device industry is the fastest growing sector in the health industry and has become one of the most promising investment hotspots in the capital market. During the 12th Five-Year Plan period, the average annual growth rate of medical devices exceeded 20%. In 2015, the total medical device market reached 300 billion. It is expected that the general specification of medical devices will double again by 2019. At present, medical imaging, ICU operating room equipment and other consumables occupy the top four in China's medical segment, accounting for 70%. It is worth noting that medical image products account for one-third of the national medical device market, ranking first. The number of new cases in China is 4.29 million per year, and the death rate is 2.81 million, accounting for 27% of the world.

According to Gao Guofan, the annual output value of medicines is about 700 billion yuan, the Chinese patent medicines are nearly 600 billion yuan, and the actual output value of medical equipment is estimated to be about 500 billion yuan. The scale of China's medical industry is less than 0.4 compared with medicines. . In the first half of 2015 and the first half of 2016, the medical device industry ranked second in the pharmaceutical product segment, with 10.3% and 12.1% respectively.

He said that China's medical device management regulations are designed in accordance with three principles. The first is to determine the system of all aspects of medical device production based on the classification management; the second is to ensure the safety and effectiveness of products based on the risk level. Under the premise, the high-risk products are pressurized, and the low-risk enterprises are decompressed. The third is to follow the spirit and requirements of promoting the transformation of government functions and deepening the reform of the administrative examination and approval system.

He introduced that in accordance with the requirements of the State Council, the leading group and office for the reform of the examination and approval system for pharmaceutical medical devices was established. The reform of the examination and approval system for medical devices was mainly carried out in five aspects: 1. Reforming the approval methods for medical devices, encouraging innovation, and innovating The special approval procedures for medical devices and the approval procedures for medical devices being developed and to be announced will solve the congestion problem. 2. Fully disclose the examination and approval information of medical devices, and announce the medical device review list and legal basis to the public. 3. Seriously investigate and punish the act of falsification. 4. Improve the quality control system for review, formulate quality management standards for evaluation, set up a professional technical review project team, and establish a review expert committee. 5. Strengthen the construction of examination and approval teams, promote the employment system of reform institutions, and engage relevant experts to participate in relevant technical reviews. The professional review system determines the quality of products, promotes the employment system of reform pilot units, and establishes a system of chief professional positions.

By the end of June, the State Food and Drug Administration had received 379 applications for special approval for innovative medical devices, completed 356 reviews, and determined that 63 products entered the special approval channel for innovative medical devices, of which 16 products have been approved. At present, the State Food and Drug Administration and relevant departments of the State Council are studying and drafting the "Approval Approval Procedure for Medical Devices." The scope includes: First, medical equipment listed in the national science and technology major projects or national key research and development plans. Second, it can meet the priority of the following five cases, can enter the priority approval, 1 diagnose or treat rare diseases, and has obvious clinical advantages; 2 diagnose or treat malignant tumors, and has obvious clinical advantages.

Gao Guozhen said that in the next five years, the medical device field will make breakthroughs in the following areas. First, medical robots, wearable medical devices, mobile and remote medical equipment, radiotherapy equipment , medical devices for diagnosis of Chinese medicine, new degradable materials, new types Implant materials, medical devices based on tissue engineering technology, etc. are areas of vigorous advancement. The second is to seize the frontier and fully explore the areas of research, such as genomics research, gene sequencing technology and gene editing technology, bioelectronics medical and cell therapy technologies. The third is to integrate resources and cultivate medical devices and medical services, including medical devices + Internet, data processing centers + independent software, clinical samples + personalized products and other shared medical services.

(Internship Editor: Li Meng)

The following is a speech record:

Gao Guozhen: Dear experts, distinguished guests, good morning! I am very happy to interact with you on medical device supervision, especially medical device registration management. When I was in the opening ceremony, the host was somewhat pessimistic about medical devices. If I stand inside and outside, I agree. Explain that the outside of the medical device is not in place. But if you look at yourself from the inside and inside, I hope that my speech today will bring you some oaths to boost.

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