The medical device industry of economic development zone gets on the fast train

Recently, it was learned from the Municipal Drug Administration that the quality system verification time of innovative medical devices has been shortened from 30 working days to 6 working days. This is another major good news for accelerating the approval speed of innovative medical devices after the State Food and Drug Administration issued the special approval procedure for innovative medical devices. As the "Jingnan pharmaceutical Valley", Beijing Economic and Technological Development Zone will focus on promoting the approval and listing of innovative medical device R & D enterprises, and accelerate the improvement of medical device industry layout with innovative medical device R & D and production enterprises as the traction.
Shorten the examination and approval process
Speed up product launch
"Medical devices should be submitted first, and the drug regulatory department should conduct preliminary examination, inspection and testing, quality system verification, production condition verification, production license issuance, and enterprise production and marketing," said the relevant person in charge of the Economic Development Zone Branch of the food and drug administration. This is the approval process for medical device enterprises to obtain the registration certificate and production license, and in the approval process, it is found that most of the medical devices R & D enterprises are not good at quality system construction, and often spend a lot of time in quality system verification. The quality system verification time of innovative medical devices in the city is shortened from 30 working days to 6 working days, which will greatly improve the speed of the whole approval process.
To speed up the verification of the quality system of medical device registration and approval is the result of the implementation of the "service package" system of key enterprises and the overall simplification and optimization of the service process of product review and approval by the drug regulatory department in accordance with the requirements of the "action plan for further optimizing the business environment in Beijing (2018-2020)".
For the headquarters of domestic and multinational pharmaceutical enterprises with high-end R & D and production capacity, the Municipal Drug regulatory department appointed leading cadres as "service housekeeper" and "attendant" to investigate and solve the actual difficulties of enterprises from the base construction, industrial development, product promotion, project financing, talent introduction and other aspects, and coordinate multi department integration of land planning, R & D investment, drug approval, financial industry To provide on-site information, policies and services for enterprises through policies and measures on work, project acceptance, public rental housing for talents, enrollment of employees' children, payment of talents rental subsidies, etc.
In order to encourage pharmaceutical enterprises to develop and innovate drugs and medical devices with national and global influence, the Municipal Drug Administration Department creatively establishes and improves the "service package" system according to the characteristics of product registration and listing. The implementation of a special person responsible for one thing, one discussion, accurate docking, full guidance. Comprehensively reduce the time limit for review and approval, quality verification, product inspection and licensing, open up a green channel for the registration of innovative drugs and medical devices, and concentrate professional and technical forces to provide high-quality consulting services for enterprises. Under such precise service, the time for quality system verification of innovative drugs and medical devices in the city has been shortened from 30 working days to 6 working days, and the inspection time limit before product registration has been shortened by more than one third.
The food and Drug Administration Economic Development Zone Branch is a pioneer in practicing the "Butler" service of medical device product review and approval. Under the implementation of the "service package" system in the economic and Technological Development Zone, the food and drug administration economic and Technological Development Zone Branch regularly held "quality system construction training meetings" for the key link of "quality system verification" in the approval of medical devices, to guide medical device R & D enterprises to build quality system in advance and prepare for product approval. The staff who supervise the R & D and production of medical device enterprises have also been transformed into the "intimate housekeeper" who guides the approval and listing of medical devices. In the process of supervision, they can understand the problems faced by enterprises, guide enterprises deeply, and solve problems for enterprises. In order to make the medical device enterprises put into production as soon as possible, the staff of the Economic Development Zone Branch of food and Drug Administration optimized the process, greatly shortened the approval time limit, and made the enterprises obtain the production license as soon as possible.
After Najie Diagnostic Reagent Co., Ltd. obtained the registration certificate of HCV nucleic acid detection kit in half the time of the routine medical device approval process, the person in charge of the company Wang Haibin specially expressed his thanks to the food and Drug Administration Economic Development Zone Branch. It turned out that the medical device product was recognized as the national virus nucleic acid detection innovative technology and included in the national innovative medical device special approval process After that, the construction of the quality control system stagnated. After the supervisors of the Economic Development Zone Branch of the food and drug administration got to know the situation, they sent professional training on the construction of the quality system for the enterprise, and entered the enterprise guidance for many times, speeding up the speed of obtaining the registration certificate for the nucleic acid determination kit of Najie diagnostic virus.
Innovative medical equipment traction
Complete industrial layout
To promote the innovation of medical device examination and approval, service policies have been issued one after another, accelerating the layout of the medical device industry in the economic development zone. In the five years since the State Food and Drug Administration issued the special approval procedure for innovative medical devices, six innovative medical devices of five enterprises in the economic and Technological Development Zone, which are the first in China, technologically at the international leading level and have significant clinical application value, have entered the special approval procedure for innovative medical devices, and three of them have obtained rapid attention through this "green channel" Certificate.
The septin9 colorectal cancer methylation gene detection kit developed by borcheng (Beijing) Technology Co., Ltd. obtained the registration certificate through this "green channel" in the year when the "special approval procedure for innovative medical devices" was released. After mass production, the product was introduced by domestic and foreign hospitals to provide early diagnosis service for patients with colorectal cancer. Since septin9 came into the market, Bocheng has successively developed the detection kits of methylation genes for early diagnosis of gastric cancer, esophageal cancer, lung cancer, pancreatic cancer and liver cancer, among which the detection kit of methylation genes for gastric cancer is about to complete the "green channel". With the help of the Management Committee of the economic and Technological Development Zone, borcheng has set up a R & D and production base integrating R & D, office and production in the zone to ensure the mass production of products after obtaining the registration certificate and production license.
The special approval policy for innovative medical devices, as well as the service and industrial environment of the economic development zone, make the innovative medical devices quickly obtain the registration certificate, which attracts more medical device R & D enterprises to gather in the economic development zone.
Among them, in the more than three years since the registration and establishment of the economic development zone and the transformation of scientific and technological achievements, Najie diagnostics obtained the registration certificate of hepatitis C virus nucleic acid detection kit in one and a half years through the special examination and approval procedures for innovative medical devices, which is twice as fast as the examination and approval time of conventional medical devices. It has officially gone from the product development stage to the production stage of medical devices, and now the innovative medical devices Mechanical products have been purchased by major hospitals, greatly improving the speed of hospital disease diagnosis. At the same time, a variety of innovative medical devices including hepatitis B virus nucleic acid detection kit developed by Najie diagnostics are in the process of approval. According to the company's marketing department, it is estimated that by the end of next year, the net profit of the enterprise's innovative medical device sales will reach 10 million yuan.
According to the statistics of the Investment Promotion Bureau of the economic development zone, up to now, 139 medical device R & D and production enterprises have gathered in the zone, of which 109 have developed medical device products and obtained registration certificates. Under the background of rapid approval of innovative medical devices, more innovative medical device R & D enterprises have been introduced into the economic development zone in recent years, which makes the R & D and production of medical devices in the Economic Development Zone cover the mainstream product direction of the industry. There are not only large-scale CT and X-ray machine R & D and production enterprises such as GE AVIC general, Varian, Weimai medical, Xinbo medical, but also Huayi precision The R & D and production enterprises of small sphygmomanometers, blood glucose meters, needle less syringes and other medical devices, as well as orthopedic aseptic implants such as Xerox and montain, and medical device R & D and production enterprises such as Bocheng and Najie diagnostic reagents, have completed the overall layout of the medical device industry.
"The overall promotion potential of the medical device industry is still great," said the relevant person in charge of the Economic Development Zone Branch of the food and drug administration. Generally speaking, there are many types of medical device enterprises in the economic development zone, and the main business directions are scattered, so it is necessary to further integrate the industrial chain. In the next step, the food and Drug Administration Economic Development Zone Branch will arrange and classify the medical device enterprises in the zone to promote the exchange, cooperation and mutual support among enterprises. At the same time, it will cooperate with the Investment Promotion Bureau and Yizhuang international investment to introduce key common R & D and production service enterprises, promote the medical device industry to gather into a more complete industrial chain, and further strengthen the medical device industry.
Leading enterprises lead the team
Focus on efficiency
In recent years, the state has issued a series of favorable policies for the medical device industry to promote the vigorous development of the medical device industry. It is pointed out that in the next three to five years, we will focus on the development of high-tech diagnostic devices and implantable devices. The national development and Reform Commission has listed medical device related equipment, medical materials and services in the guidance catalogue of key products and services of strategic emerging products.
With the strong support of national policies, China's medical device industry also ushered in rapid development. According to the statistical data of "analysis report on market demand forecast and investment strategic planning of China's medical device industry" released by foresight Industry Research Institute, by 2017, the market sales scale of China's medical device industry had increased to 523.3 billion yuan, an increase of 8.37% over the previous year. It is preliminarily estimated that in 2018, the market sales scale of China's medical device industry will be close to 600 billion yuan, an increase of about 13% over the previous year. According to the forecast industry research institute, the global medical device market will reach US $522 billion in 2022, with a compound growth rate of 5.1% from 2016 to 2022.
The improvement of living standards and the enhancement of health care awareness have promoted the increase of consumption of health care products and services. The public pays more attention to the medical and health care consumption related to life and health. The functions of medical devices are becoming more and more diversified, and the concept of medical consumption is gradually changing from treatment to disease prevention and health care. The aging trend in China will become the internal driving force for the long-term rapid growth of medical devices.
Facing the rapid development of medical device industry, Varian Medical equipment (Beijing) Co., Ltd. developed and produced the latest generation of intelligent accelerator halcyon system in the economic development zone at the beginning of this year. It is the first medical linear accelerator in the world to realize 100% image guidance. According to the location, shape, size and distribution of tumor, the radiation dose is focused on tumor cells to the maximum extent To achieve high precision, high dose, high efficacy and low injury. It is expected that the R & D and production base of the most complete product line of Wali safety ball will be established in Yizhuang next year.
Varian's new step of innovation and development is not an example. In the medical device industry of Economic Development Zone, all enterprises are concentrating on the rapid development of the industry.
Ge medical company officially put into production the production line of new breast X-ray machine in May, opening the way for the equipment to supply from the economic development zone to the world and to cover hospitals at all levels in China, so as to provide support for improving the early screening rate of breast cancer in China. The newly developed portable ultrasonic light scattering dual-mode breast diagnosis system (ruguangchao) of Xinbo Medical Technology Co., Ltd. has successfully obtained the medical device registration certificate issued by Beijing food and Drug Administration in April. It will be popularized and applied to rural areas and grass-roots units by virtue of its portable characteristics, so as to improve the early screening rate of breast cancer and reduce the mortality rate of breast cancer patients.
Many new products are in the stage of R & D, approval and marketing, forming a new product echelon and accumulating strength to go to the market; Huayi Jingdian and kuaishuer promote the continuous updating and iteration of products and launch intelligent blood glucose monitor and needle free syringe products; and Montayne and Xerox are updating the production process and constantly improving the quality of bone prosthesis And so on.
The development of the medical device industry has provided assistance for the development of the biomedical health leading industry in the economic development zone. According to the estimation of the Investment Promotion Bureau, the output value of the biomedical health industry in the Economic Development Zone reached 24.3 billion yuan in the first half of the year, up 16% year on year.