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Jiangsu Huaxia Ruitai Medical Equipment Co., Ltd. won the title of "Jiangsu High-tech Enterprise" Recently, Jiangsu Huaxia Ruitai Medical Devices Co., Ltd. was jointly recognized as "Jiangsu High-tech Enterprise" by Jiangsu Provincial Department of Science and Technology, Jiangsu Provincial Department of Finance, Jiangsu Provincial State Taxation Bureau, and Jiangsu Provincial Local Taxation Bureau. This certification marks that the company has reached a relatively high level in terms of technological innovation, R&D capabilities, intellectual property rights, and market competition, and will receive more attention and support from the government. As an enterprise focusing on the R&D, production and sales of medical devices, the company has been committed to innovation and technological upgrading, and continuously improves product quality and service levels to meet customer needs and market changes. In the future, the company will continue to adhere to the business philosophy of "people-oriented, technological innovation, and service-oriented", continuously strengthen cooperation with well-known domestic and foreign companies, promote industry-university-research cooperation, enhance core competitiveness, and provide customers with better products and services. Make greater contributions to the development of the medical industry.

Gently and slowly insert the swab through the nasal cavity. The swab reaches the finger mark or stays for a few seconds after encountering resistance to absorb secretions; (usually stay for 15-30 seconds, then gently rotate 3 times). Gently swirl to remove the swab and place it in the virus sampling tube (in the transport medium); break the swab tail along the breaking point so that it is completely in the tube. Tighten the cap, and if you need to collect from both nostrils, you should use another swab. Nasal swab sampling precautions The sampler stands at the side of the patient to take samples, and asks the patient to pull down the mask to expose only the nostrils. Once the sneeze reflex occurs, the patient can cover it with his elbow or a tissue. The sampler is not directly in front of the patient, and the risk of exposure is quite low. In clinical practice, many patients have hypertrophic turbinates and narrow nasal passages. When the throat swab feels resistance, they cannot rashly exert force. They can try to change the nasal cavity or directly change to oropharyngeal swab collection. People with nasal allergy symptoms can easily induce sneezing. It is recommended to take an oropharyngeal swab.

People's Daily Online, Beijing, May 28 (Reporter Sun Hongli) In recent years, my country's medical device industry has developed vigorously, and innovative products have continued to emerge. At the same time, the problem of unbalanced and insufficient development still exists, and violations of laws and regulations occur from time to time, which seriously damages the rights and interests of public health. According to the official website of the State Food and Drug Administration, in order to effectively strengthen the investigation and management of potential risks of medical devices, the State Food and Drug Administration issued a notice recently, requesting to comprehensively strengthen the consultation on the quality and safety risks of medical devices. The notice pointed out that comprehensively strengthening medical device quality and safety risk consultation is of great significance to improving the pertinence, targeting and effectiveness of medical device quality and safety supervision. Drug regulatory authorities at all levels should comprehensively strengthen consultations on the quality and safety risks of medical devices, timely discover and effectively deal with potential risks of medical device quality and safety, further implement the main responsibility of enterprises and the regulatory responsibilities of regulatory authorities, and accelerate the establishment of risk identification, risk assessment and risk management and control systems. The integrated risk management mechanism effectively guarantees the quality and safety of medical devices in my country. Regular risk consultations The notice requires that drug regulatory authorities at all levels should regularly organize and carry out medical device quality and safety risk consultations based on local work conditions. To carry out risk consultations, it is necessary to focus on risks, enterprises, products, and disposal, and closely focus on the hidden quality and safety risks discovered in the supervision of medical devices and notified by relevant departments. Comprehensively sort out risk information The drug regulatory authorities at all levels should comprehensively sort out the information found in the supervision and inspection, supervision and sampling inspection, adverse event monitoring, online sales monitoring, complaint reporting, case investigation, product recall, public opinion monitoring and other regulatory work before risk consultation and relevant departments. Risk Information. It is necessary to make full use of big data and other information technology means to systematically sort out. Scientifically carry out risk research and judgment The drug regulatory authorities at all levels should evaluate and analyze the risk information sorted out through collective discussions, scientific analysis, and comprehensive research and judgment, from the aspects of product quality, social impact, legal risk, etc. treatment measures. It is necessary to focus on the situation where the quality system inspection and rectification are not in place, the repeated random inspections are unqualified, the adverse event report indicates that the product has unconventional risks, the complaints and reports and public opinion are more concentrated and other risk factors are more prominent and the risk causes are more complicated. Ensure risk management is in place Drug regulatory departments at all levels must strictly implement the corporate and territorial regulatory responsibilities, and timely control and eliminate various hidden risks in accordance with the disposal measures determined by the consultation. It is necessary to urge enterprises to implement their main responsibilities, take effective measures to eliminate hidden risks, and actively cooperate with regulatory authorities to do a good job in risk disposal.

Guangming.com (Reporter Zhang Mengfan) At the press conference held by the National Health and Health Commission on July 22, Yuan Lin, director of the Drug Administration Department of the State Food and Drug Administration, said that the State Food and Drug Administration will continue to strengthen the quality supervision of the selected products, and effectively do Focus on the quality supervision of the selected drugs and medical devices, continue to urge the selected enterprises to implement the main responsibility for quality, and better protect the safety of medical devices for the general public. First of all, the State Food and Drug Administration has specially deployed to strengthen the quality supervision of selected drugs in centralized procurement. Organize provincial drug regulatory authorities to conduct full-coverage supervision and inspection, product sampling inspection, and continuous strengthening of adverse reaction monitoring on selected drugs in centralized procurement. Secondly, continue to strengthen the quality supervision of selected medical devices in centralized procurement. On the one hand, guide the provincial drug supervision and administration departments to supervise enterprises, strictly implement the main responsibility for product quality and safety, and carry out full-coverage inspections of selected enterprises and products for centralized procurement; In 2022, the State Food and Drug Administration will organize a full-coverage quality sampling inspection of vascular stent varieties, artificial joints and other varieties selected by the national centralized procurement. So far, the sampling results are all qualified. Third, further urge the implementation of the main responsibility for the quality of the marketing license holder or the manufacturer, and strictly implement the requirements of GMP (Good Manufacturing Practice for Pharmaceutical Products). Specifically, the holder or the manufacturer should organize production in strict accordance with the approved standards and processes, strictly conduct the review and control of raw and auxiliary material suppliers, strictly conduct research and management on post-marketing changes of drugs, study and judge the identified risks, and timely Take effective control measures. Establish and improve an information-based traceability system to collect traceability information throughout the process. Fourth, carry out in-depth supervision and inspection of selected drugs and medical devices in centralized procurement. In response to the violation of the drug production quality management standards by individual enterprises found in the on-site inspection, measures such as suspending the production and sales of related enterprises' products, recalling listed products, etc., are taken according to law, and coordination and cooperation are made to ensure product supply. In response to the unqualified situation of individual imported drugs found in the sampling inspection, risk control measures shall be taken in a timely manner in accordance with the law, and joint disciplinary actions shall be implemented in cooperation with the medical insurance department. In terms of the supervision of selected products for medical devices, from January to June 2022, the provincial drug administration departments will inspect 221 companies, 1,371 distribution companies, and more than 10,000 users. The inspection results show that the overall quality The operation of the management system is generally good. Fifth, strengthen the supervision and guidance of cases and complaints and reports, and properly handle and handle complaints, reports, letters and visits, public opinions and other related case clues involving the production, circulation, and use of the selected drugs and equipment in centralized procurement. Organize the selection of typical cases of drugs and medical devices, and in the form of a compilation of typical cases, further guide the local drug regulatory authorities to strengthen the investigation and handling of cases, and actively cooperate with relevant departments to investigate and deal with violations of laws and regulations.

The first medical drama focuses on "domestic fully magnetic levitation artificial heart" There are over 100 people in the country who use artificial hearts Recently, the medical drama "All About Doctor Tang" is on the air. The drama focuses on the cardiac surgeon, one major case per episode, and intensive medical knowledge points, which made many netizens feel that there is finally a medical drama that does not fall in love through the workplace. "All About Doctor Tang" is also the first drama in China that pays attention to "full magnetic levitation artificial heart". The reporter also learned that the artificial heart, a medical device that sounds full of technology, has actually come to us, and more than 100 people have used the "artificial heart" nationwide. Intern Cao Min Yangzi Evening News/Ziniu News reporter Yang Yan Trainee reporter Lv Yanlin watch drama In the drama "All About Doctor Tang", the research and development of the domestic "full magnetic levitation artificial heart" is one of the main lines, and its importance has been emphasized since the first time it was mentioned in the play. Dr. Tang's patient had to wait for a heart transplant to live a normal life due to heart problems. It was hard to wait for a donor, and because other patients were more urgent, the donor was distributed to others. It was also from this time that Dr. Tang, who originally thought that as long as the operation was done, began to change, realized the importance of artificial hearts, and began to participate in the research and development of artificial hearts. look at reality The future has come, and he is now walking like a fly with an artificial heart On July 1, 2021, Mr. Liu, 34, received the first artificial heart implantation operation in Jiangsu Province at the Jiangsu Provincial People's Hospital (The First Affiliated Hospital of Nanjing Medical University). Implantation of a fluid-suspended ventricular assist device. Before that, Mr. Liu had been severely affected by heart disease for five years. He had chest tightness, asthma, and swollen legs. In severe cases, he could not even lie down to sleep. After falling asleep, he also had apnea. He has been in the hospital many times. He was discharged from the hospital, but his condition was still deteriorating. I got sick several times last year, and I have reached the point where I can't take care of myself. After receiving a consultation notice from the Cardiology Department, Professor Shao Yongfeng, Director of Cardiac and Great Vascular Surgery, met Mr. Liu. Mr. Liu has end-stage heart failure, but with a weight of 112 kg, it is almost impossible to find a suitable donor. After consultation and discussion with multidisciplinary experts, the team of doctors finally and carefully decided to implant a ventricular assist device for Mr. Liu, that is, to install an artificial heart. On July 1, 2021, the team of Professor Shao Yongfeng of Cardiac and Great Vascular Surgery successfully implanted an artificial heart for Mr. Liu. After the operation, Mr. Liu had a "life-saving backpack" that could not be put down - the "small box" in the backpack was the controller of his new heart, which was connected to the body through a wire conduit, and there were two batteries on both sides. Each battery can be used for 6 hours. Mr. Liu needs to charge his new heart every day like everyone charges a mobile phone. Shao Yongfeng told reporters from Yangzi Evening News/Ziniu News that the "artificial heart" implanted in Mr. Liu's body is the first implantable magnetic fluid suspension ventricular assist device in Jiangsu Province. The blood pump implanted in the heart is only 180 grams. The external controller is waterproof to minimize the impact on life. Director Shao Yongfeng also told reporters that they have kept in touch with Mr. Liu since the operation for a year. Mr. Liu is currently in good physical condition. Walking around the community, he can walk like a fly. Doctor's interpretation The artificial heart is a "plug-in" for the heart that can't beat At present, Jiangsu Provincial People's Hospital, Nanjing First Hospital and other hospitals have completed the implantation of "artificial heart", and the lightest implanted pump body is only 90 grams. According to Professor Shao Yongfeng, there are actually two types of artificial hearts. One is a full artificial heart, which can replace the work of the left and right ventricles, and the other is a semi-artificial heart, which assists a separate ventricle. The left ventricular assist device has been used for the longest time and has the largest number, and the technology has been relatively mature. Implantation of a ventricular assist device in the left ventricle is equivalent to placing an artificial pump in the heart. Its core structure is a special centrifugal magnetic levitation blood pump system. The drive motor generates a stable rotating magnetic field, which drives the impeller rotor to rotate at a high speed. The blood will flow from the left ventricle into the auxiliary device, powered by the artificial pump, and flow out to the aorta, forming a systemic circulation. The artificial heart can replace 90% of the pumping function of the heart, allowing the heart to rest, and at the same time ensuring the perfusion of important organs such as the brain, kidneys, and liver. "The patients who use artificial hearts are mainly patients with heart failure." Director Shao Yongfeng said that heart failure is the end stage of the development of heart disease. For most patients with heart failure, the life-saving treatment plan is to implement heart transplantation and Artificial heart implant surgery. According to statistics, there are at least 10 million heart failure patients in my country, and more than 1 million patients with end-stage heart failure who need to undergo heart transplantation, and only about 500 heart transplantation operations are performed every year. Due to factors such as the scarcity of donors and the difficulty of surgical operations, many heart failure patients unfortunately died while waiting for a donor for a long time. The artificial heart is to open a "plug-in" for these hearts that have not been able to beat. After the operation, the original heart function of some patients may be restored. At this time, the artificial heart can be removed. There are also many patients who rely on ventricular assist devices to prolong their lives and wait for a donor. To save more patients, expect more "Chinese Heart" to be launched Director Shao Yongfeng told reporters from Yangzi Evening News/Ziniu News that more than 100 people have used artificial hearts in China, and the longest survival time is more than five years. In foreign countries, the application of artificial hearts is earlier, and the current volume of artificial heart operations has exceeded that of heart transplantation. "Artificial hearts need to be more widely used. The popularization of technology is one aspect, and the price is also a restrictive factor." Director Shao Yongfeng said that most of the current domestic artificial heart cases belong to clinical trials. If it is actually used clinically, the burden on patients The cost of the artificial heart is more than one million. Such a price will definitely restrict the general application of artificial hearts, but the field of artificial hearts is still full of hope. The first implantable magnetic fluid suspension ventricular assist device in Jiangsu Province has set four "uniques" in China - the only pure state-owned enterprise production; the only medical-industrial combination from beginning to end; the only domestic original independent intellectual property rights; the only complete set of products domestically developed. At present, there are many hospital heart center doctors in China participating in the research and development of domestic artificial hearts. The cost of the heart is fully expected to come down. Coupled with medical insurance covering part of the cost, more patients will be able to use this life-saving technology. remind Initial heart insufficiency is easy to ignore, regular physical examination can find signs of problems Although cardiac insufficiency may cause symptoms such as dyspnea, lower extremity and ankle edema, or even ascites and pleural effusion, due to the compensatory function of the heart, there are no obvious symptoms in the early stage of the disease, and it is easy to be confused with problems such as fatigue. Director Shao Yongfeng reminded that if early heart problems are found, it is still necessary to call for regular physical examinations. An electrocardiogram or echocardiogram can detect signs of heart problems. If a problem is suspected in the initial physical examination, cardiac catheterization, arterial blood gas analysis, pulmonary function, 6-minute walk test, etc. are also required. Early detection and scientific intervention can prolong the "use period" of the heart as much as possible.

The medical device industry continues to develop with the growth of human health needs. It is known as a sunrise industry and is a field that developed countries around the world are competing for. At present, my country is gradually entering an aging society and the support for the industry at the national policy level has made my country's medical device market. Rapid growth in scale. With the improvement of the living standards of global residents and the enhancement of health care awareness, the demand for medical device products has continued to grow in recent years. It is estimated that the market size of my country's medical device industry will exceed 900 billion yuan in 2022. The golden period is coming, and medical devices will usher in Unprecedented development opportunities, showing a huge market space. In order to meet the growing demand for healthy life of the people, the "2022 World Health Expo and International Medical Equipment Exhibition" will be held in Wuhan from August 5 to 7, 2022. This expo will focus on medical equipment, protective materials, traditional Chinese medicine and traditional Chinese medicine. , medical imaging, in vitro diagnosis, electronics, optics, first aid, rehabilitation nursing, hospital construction, mobile medical and other medical equipment industry chain. The purpose of this expo is to provide a platform for communication, trade and cooperation for the global health industry, to provide high-quality services for colleagues in the industry, to further promote the healthy development of the health industry, and to provide a broader platform for the branding and professional development of the industry. Space.

Medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials, and other similar or related items that are directly or indirectly used in the human body, including required computer software; their utility is mainly obtained through physical means, not Obtained by pharmacological, immunological or metabolic means, or although these means are involved but only play a supporting role; its purpose is the diagnosis, prevention, monitoring, treatment or alleviation of disease; the diagnosis, monitoring, treatment, alleviation or function of injury Compensation; examination, replacement, regulation or support of physiological structures or processes; life support or maintenance; pregnancy control; providing information for medical or diagnostic purposes by examining samples from the human body.

"The 14th Five-Year Plan for Bioeconomic Development" Issuance The scale of my country's bio-economy will reach a new level (Sankei Observation) What is the bioeconomy? As small as a seed and a dose of vaccine, as large as a power plant or an industrial park, they may all belong to the category of bio-economy. In Yangling, Shaanxi, China Yangling Technology Center of Syngenta Group, rows of automated greenhouses are neatly arranged, and the corn being developed is growing well. Here, the scientific research team used biological breeding technology to complete the transformation of nearly 400 generations of maize in just a few months. Shanghai Zhangjiang, Cell and Gene Industrial Park, the research and development of T-cell immunotherapy (referred to as CAR-T therapy) is in full swing. The anti-cancer guardian T cells from the patient's body are extracted, and the "Beidou Navigation" CAR is added to turn them into more combative CAR-T cells, which are then infused back into the patient's body. This new type of precise targeted therapy is bringing anti-cancer drugs to patients. Cancer New Hope. Heze, Shandong, National Energy's Shanxian Biomass Direct Combustion Power Generation Demonstration Project, an extraction-condensing steam turbine generator set, combined with a high-temperature and high-pressure water-cooled vibrating furnace, using straw as fuel, can generate 229 million kWh of green electricity a year. Biopower generation not only helps to solve the problem of straw burning in rural areas, but also reduces carbon dioxide emissions by more than 100,000 tons and sulfur dioxide by about 1,500 tons per year. A few days ago, the "14th Five-Year Plan for Bio-economic Development" (hereinafter referred to as the "Plan") was officially issued. This is my country's first five-year bioeconomy plan. What benefits will the "Plan" bring to the development of bio-economy? What are the expectations of the company? The reporter conducted an interview. Why is the bioeconomy important? The important content of my country's science and technology economic strategy for a period of time in the future The "Plan" clearly states that the bioeconomy is driven by the development and progress of life science and biotechnology, based on the protection, development and utilization of biological resources, and extensively and deeply integrates industries such as medicine, health, agriculture, forestry, energy, environmental protection, and materials. "Biotechnology is one of the most important innovative technology clusters in the 21st century. It has remarkable characteristics such as breakthrough and leadership. It has become an effective force to promote future development and is of great significance in promoting the high-quality development of society and people's livelihood." Chinese Academy of Sciences Science and Technology Xu Hang, deputy director of the Promotion and Development Bureau, said. As one of the countries with the most abundant biological resources and the broadest market for life and health consumption in the world, my country has complete categories and systems of biological industries, and has favorable conditions for accelerating the development of the biological economy. Especially since the 18th National Congress of the Communist Party of China, my country has made remarkable achievements in the innovation and development of bio-economy. Technological breakthroughs continue to emerge. Looking at the "point", artemisinin has achieved the "zero breakthrough" of the Nobel Prize in the field of natural science in my country; looking at the "face", my country ranks second in the world in the number of innovative drugs under development, in genetic testing, super rice, synthetic starch, vaccines Comparative advantages have been formed in other fields. Industrial innovation continues to be active. In recent years, the field of biology has become a hot spot for investment, with biological companies accounting for 1/3 of the companies listed on the Science and Technology Innovation Board. The volume of biological manufacturing has been further expanded, and modern biological fermentation products account for more than 70% of the global share. The regional agglomeration effect is obvious. The Beijing-Tianjin-Hebei region, the Yangtze River Delta, the Guangdong-Hong Kong-Macao Greater Bay Area, and the Chengdu-Chongqing Economic Circle have become my country's bioeconomy innovation highlands. About 80% of the listed companies in the country, 90% of the national first-class new drugs, and 85% of the specially approved products for innovative medical devices come from these regions. The development of my country's bio-economy also faces many challenges. For example, the original innovation capability is still relatively weak, the accumulation of basic life science theories, underlying key common technologies, high-end instruments and reagents, and biological information resources is insufficient, the technological innovation system is still imperfect, and there are still relatively few companies with international competitiveness. Xu Tao, academician of the Chinese Academy of Sciences, emphasized that the "14th Five-Year Plan" period is an important opportunity period for the accelerated evolution of biotechnology, the rapid growth of life and health needs, and the rapid development of the bio-industry. Only by successfully grasping this major opportunity period, speeding up the resolution of key core technologies that restrict the development of bio-economy, and better mastering the basic theories and original methods in the field of life sciences, can China continuously improve the quality and efficiency of industrial development and accelerate the realization of China's bio-economy From big to strong and high-quality development. The introduction of the "Plan" is just in time. "The "Plan" takes bioeconomy as an important part of my country's science and technology and economic strategy for a period of time in the future, provides new solutions to major challenges such as life and health, climate change, resource and energy security, and food security, and contributes to building a higher level of healthy China. , Beautiful China, and Safe China," said Wang Xiang, deputy director of the High-Tech Department of the National Development and Reform Commission. Which areas deserve attention? Focus on cultivating and expanding the four pillar industries of medical health, bio-agriculture, bio-energy and bio-environmental protection, and bio-information The proportion of economic added value in GDP has increased steadily, the number of enterprises with annual operating income of more than 10 billion yuan has increased significantly, and the scale of the total bio-economy has reached a new level... The "Planning" has an impact on the development of the bio-economy during the "14th Five-Year Plan" period. Development sets clear goals. However, the bioeconomy involves a wide range and covers many industrial fields. To achieve the goal, it is necessary to highlight the key points. To this end, the "Planning" clearly regards meeting the new needs of the people for "medicine", "food", "beauty" and "safety" as the key areas for the future development of the bio-economy, and proposes to cultivate and strengthen medical and health care, bio-agriculture, bio-energy and bio-environmental protection, and bio-economy. Four pillar industries of information. The health industry has received the most attention. The "Planning" proposes to follow the new trend of "treatment-centered" to "health-centered", and develop biomedicine oriented to people's life and health. Focus on medicines, vaccines, advanced diagnosis and treatment technologies and equipment, biomedical materials, etc., improve original innovation capabilities, and enhance the supply chain guarantee level of high-end biomedical products and equipment. "Next, the Ministry of Industry and Information Technology will work with relevant departments to implement the pharmaceutical pilot enterprise cultivation project, combined with the implementation of policies such as generic drug consistency evaluation and volume procurement, to support large enterprises in implementing innovation and transformation, and form a group of highly internationalized, global layout development. Large pharmaceutical companies," said Zhou Jian, deputy director of the Consumer Goods Industry Department of the Ministry of Industry and Information Technology. The agricultural industry is related to the livelihood of the people. The "Planning" proposes to develop biological agriculture oriented to agricultural modernization in line with the new trend from "solving food and clothing" to "diversifying nutrition". Focus on biological breeding, biological fertilizers, biological feeds, biological pesticides, etc., launch a new generation of agricultural biological products, and improve the industrial system for the protection, development and utilization of germplasm resources. Among them, the "Planning" makes it clear that it will explore and develop new foods such as "artificial protein", realize the iterative upgrading of the food industry, and reduce the pressure on environmental resources brought by the traditional breeding industry. At present, the advantages of biological agriculture have begun to emerge. In Jining City, Shandong, the use of bio-compound fertilizer "Bacteria is more abundant" for corn planting not only increases yield by 7.31% compared with traditional chemical fertilizers, but also improves soil quality. In Heyuan City, Guangdong, Sinochem Bio-Organic Fertilizer was applied to chickpea peach. Compared with ordinary fertilizers, the fruit set rate increased by 15%, the average weight gain of the fruit during the mature picking period was 14%, and the drought and waterlogging tolerance of the crop was also improved simultaneously. The bioenergy and bioenvironmental protection industries have great potential. The "Plan" makes it clear that in line with the new trend of "pursuing production capacity and efficiency" to "adhering to ecological priority", develop green and low-carbon biomass replacement applications. For example, develop high-performance bio-environmental materials and biological preparations to help environmental protection and pollution control; carry out research and development and cultivation of new biomass energy technologies, promote the transformation of fossil energy into green and low-carbon renewable energy, and accelerate bio-natural gas, cellulosic ethanol, and algae. Biofuel and other key technology research and development and equipment manufacturing. The bioinformatics industry has broad prospects. The "Planning" requires that for major diseases such as cardiovascular and cerebrovascular diseases, tumors, respiratory diseases, diabetes and other major diseases, the development of intelligent auxiliary decision-making knowledge models and algorithms to assist in the research and development of personalized new drugs; the use of 5G, blockchain, Internet of Things and other cutting-edge technologies to achieve Full life cycle management of drugs and vaccines from production to use; deepen the application of health big data in medical research, education and training, clinical diagnosis and treatment, product development, industry governance, and medical insurance payment. How to achieve better development? "Insist on risk controllable" is one of the important principles Biosecurity is related to people's life and health, and to the long-term stability of the country. To develop the bio-economy, "adhering to the control of risks" is one of the important principles. On the one hand, the "Plan" makes it clear that the construction of a biosafety guarantee system should be accelerated. Improve the construction of the basic security system, such as improving the biosecurity governance mechanism of party committee leadership, government responsibility, social coordination, public participation, and legal protection, intensive construction of biosecurity infrastructure, and enhancement of biosecurity scientific research and production support capabilities. Improve the efficiency of emergency material reserve, production and scheduling, and improve various epidemic monitoring, early warning and prevention systems. On the other hand, the "Plan" proposes to actively promote the protection and utilization of biological resources. Improve the biological resources supervision system, carry out a comprehensive census of biological resources, and build biological resource databases and digital "libraries". Standardize the safe sharing of biological resources, establish a national biological resource sharing system, promote the controlled sharing and safe exchange of biological resources, and realize the unified exchange and sharing of biological data resources in my country. To keep the bottom line of safety, and to actively innovate supervision, can we create a good environment for the innovation and development of biotechnology. In this regard, the "Plan" proposes to build a number of bio-economy pilot zones, and pilot reform measures in key links in the bio-economy field such as technological innovation, access and supervision. Corresponding explorations have been made in Shanghai Pudong New Area. In the development and production of CAR-T cell therapy products, some raw materials and preparations need to be imported, and the storage temperature needs to be maintained at minus 196 degrees Celsius. How to not only ensure safety, but also improve the speed of customs clearance? In 2020, Shanghai Pudong New Area innovatively launched a "white list" system for pilot enterprises of special items imported into China. Enterprises selected into the "white list" can estimate the demand for biological products in advance, submit an import application once, and approve it once, without the need to apply batch by batch. The front end has been released, and follow-up supervision has to keep up. In Pudong New Area, multiple departments are involved in risk control through a joint supervision platform. After an enterprise submits an application for consumption, the Commerce Commission, Customs and other departments will jointly conduct a centralized assessment and issue a customs clearance certificate. The customs then released the port, and the establishment of diplomatic relations and the public security department conducted real-time supervision on the road. The health and health commission carried out on-site biosafety laboratory supervision on the enterprise, and the ecological environment bureau was responsible for the consumption of imported special items after laboratory consumption and medical waste. manage. Since the pilot was launched, the "whitelist" system has achieved good results, and the speed of enterprise research and development has been significantly improved. In 2021, the number of innovative drugs and innovative medical devices approved for listing in my country will be the highest in the past five years; the operating income of sub-sectors such as biological drug manufacturing, genetically engineered drugs and vaccine manufacturing will increase by 113.8% year-on-year, and the profit will be the largest in the total profit of the pharmaceutical industry. The proportion reached 41.7%. To develop the bio-economy, financial support is indispensable. The "Plan" clarifies that in order to support the development of the bio-economy, my country will make overall use of all levels and types of relevant financial funds to support the development of the bio-economy, increase support for bio-related technological innovation and product services; continue to develop the first (set) of major technologies The first pilot of the insurance compensation mechanism for equipment and new materials; encourage local governments to establish and improve the fiscal subsidy policy for biomass energy. "Next, relevant local and national departments will speed up the formulation of supporting policies, jointly promote the development and growth of the bio-economy, and ensure the implementation of the goals and overall strategic tasks of the Plan," said Wang Xiang.

There are three situations in which medical device manufacturers sell medical devices: 1. If you sell your own registered medical devices and sell them at your own residence or production address, you do not need to apply for a medical device business license. 2. If the self-registered medical devices are not sold at their own residence or production address, they must apply for a medical device business license. 3. For the entrusted processing of medical devices of other registrants, if there is no entrusted sales by the registrants, the entrusted medical devices cannot be sold regardless of whether they have a medical device business license or not. If there is entrusted sales, a medical device business license is required to sell.

On May 31, the Medical Device Supervision Department of the State Food and Drug Administration organized a report meeting on the investigation and rectification of potential quality and safety risks in the operation and use of medical devices. If there are problems, study the next steps, further strengthen the supervision of the operation and use of medical devices, and improve the quality and safety assurance level of medical devices. The meeting pointed out that the safety and effectiveness of medical devices are closely related to public health and life safety. The drug administration departments at all levels must be strict and practical, and further promote the quality supervision of the operation and use of medical devices. Under the current situation of epidemic prevention and control, drug regulatory departments at all levels must keep in mind their responsibilities and missions, implement various tasks, and ensure the effectiveness of supervision. It is reported that in order to promote the solid development of the rectification of medical devices, the local drug regulatory departments actively plan, innovate in the regulatory system and form, and make solid progress. The Jiangsu Provincial Bureau has launched the "Li Jian 2022" special action, and the Guangdong Provincial Bureau has included it in the "Work Style Construction Promotion Year" project. Provincial epidemic prevention and control equipment, carry out full coverage sampling inspections in stages, at different levels, and by varieties. The Market Bureau of Weihai City, Shandong Province included the investigation and management of hidden dangers and special drug rectification actions into the "top-ranking project". The High-tech Branch of the Market Bureau of Baoji City, Shaanxi Province established a work task ledger, explored the implementation of the "monthly plan, weekly notification, quarterly evaluation" system, and solidly promoted the investigation and rectification action. For business entities and supervisory units, the Market Bureau of Chengguan District, Lanzhou City, Gansu Province, the Market Bureau of Chengdu High-tech Zone, Sichuan Province, and the Market Bureau of Weihai City, Shandong Province have formulated a double-check on the "risk of medical device products" and "risk of regulatory responsibility". Procedures or lists, to promote the implementation of the responsibilities of both business entities and regulators. For the next step, the meeting put forward requirements: drug administration departments at all levels should strengthen communication and cooperation with health, public security and other departments under the leadership of local party committees and governments and the joint epidemic prevention and control mechanism to form a joint supervision force. Make every effort to build a solid bottom line on the safety of medical device products for epidemic prevention and control, and make new contributions to epidemic prevention and control. The Medical Device Supervision Department of the State Food and Drug Administration, the China Inspection Institute, the Inspection Center, the Evaluation Center, the Acceptance and Reporting Center, and the responsible comrades of the drug regulatory departments of more than ten provinces and cities including Jiangsu Province and Guangdong Province attended the meeting in the main venue and branch venues respectively. .

Industry Hotspots of the Week Midday news on medical trends Last week, Omicron continued to mutate, allowing the outbreak to spread widely around the world. The World Health Organization recently updated the total global death toll from COVID-19 to 14.9 million, including direct and indirect deaths. The domestic epidemic is still running at a high level, and large-scale epidemics are intertwined with sporadic epidemics. From April 30 to May 5, the country reported an average of more than 5,800 new infections per day, a drop of 80% from the peak period. After more than a month of epidemic control in Shanghai, the number of newly confirmed cases continued to decline for several consecutive days. At the same time, Shanghai announced that the city's college entrance examination will be postponed to July 7th to 9th, and the high school entrance examination will be postponed to July. Held from 11th to 12th. In terms of company dynamics, due to the risk of thrombosis, Johnson & Johnson's new crown vaccine was required by the FDA to restrict the use; due to potential quality problems, Novartis suspended the production of two radioligand drugs... In terms of personnel changes, Fresenius Medical Care hired the next CEO, who once led the Philips Connected Care Department; Hengrui announced the latest executive adjustment! Appointed Dai Hongbin as general manager; Bojian CEO is about to leave; Beijing Kexing Zhongwei was accused of laying off a large number of employees before the year-end bonus... personnel changes 1. Fresenius Medical Care hires next CEO, who led Philips Connected Care Recently, Fresenius Medical Care announced that it has hired Carla Kriwet as its next CEO, effective January 1, 2023. Kriwet spent seven years at Philips from 2013-2020, eventually leading the Connected Care division as CEO and serving on the company's executive committee. From July 2020 to April 2022, Kriwet was CEO and President at BSH Hausgeräte (Household Appliances) Ltd. During this period, BSH, with around 62,000 employees and 40 production plants, achieved record sales for two consecutive years, reaching 15.6 billion euros by 2021.

Radius expanded: from 5 cities to the whole province In February, the Liaoyang Municipal Medical Insurance Bureau released an "Implementation Plan for the Procurement of Some Medical Consumables in 2022 by the Inter-City Procurement Alliance (Draft for Comments" (hereinafter referred to as the "Draft for Comments") on the Liaoning Provincial Centralized Purchasing Network for Drugs and Medical Consumables. Three months later, on May 9, the "2022 Implementation Plan for the Centralized Procurement of Medical Consumables in Medical Institutions" (hereinafter referred to as the "Plan") was officially released on the Liaoning Provincial Centralized Purchasing Network of Medicines and Medical Consumables, and the "Draft "The 5 cities in the scope are expanded to the whole province. The "Plan" clarifies that the purchase targets are infusion sets and pre-filled catheter irrigators that have obtained national medical insurance codes. Led by the Liaoyang Municipal Medical Security Bureau and relying on the Liaoning Provincial Medical Institutions Drug and Medical Consumables Purchasing Alliance to carry out this volume purchase. With 90% of the actual purchase volume reported by medical and health institutions in 2021 as the intended purchase volume, the "2022 Partial Medical Consumables with Volume Purchase Catalog" will be formed, and the procurement cycle is 2 years. The main body of procurement is the province's public medical and health institutions, and medical insurance designated social medical institutions are encouraged to participate. The participating medical and health institutions uniformly implement the relevant regulations and procurement results of Liaoning Province's centralized procurement with volume. For the "Plan", Cyberblue Equipment contacted the relevant person in charge of the procurement of the medical insurance bureau of a city in Liaoning Province, who made an exclusive interpretation of the overall situation such as the shortlisted conditions, negotiation process, and procurement cycle in the centralized procurement documents. The person in charge told Cyberblue Equipment: "Liaoyang, Jinzhou, Panjin, Benxi, and Fuxin were the five cities to carry out bulk procurement work when the draft was first solicited, and later the clinical substitutability of these two types of low-value consumables was considered. Stronger and more competitive in the market, we decided to do it together in the whole province." It is understood that at first the "Draft" wrote that "the top two products in the total number of purchases in the alliance region in 2021 and the product with the largest number of purchases in each alliance region will directly enter the quotation link after being confirmed by the review team", while The "Plan" has been changed to "The top five products in the total number of purchases in the alliance region in 2021, the first product in each alliance region, and the top two products in Shenyang and Dalian in the number of purchases. After the review team After confirmation, go directly to the quotation link." The reason for this change, the person in charge explained, is because the scale of each city is different, and the products with larger coverage in big cities will also be purchased in larger quantities at the provincial level. However, related products with relatively large coverage in some small cities may not be ranked so high in purchase volume in the province, but they are still products with good quality and stable supply. Even if this product does not rank in the top five in the province It ranks first in the number of purchases in a single alliance area, and can directly enter the quotation link after being confirmed by experts. "The purpose is to ensure the continuity of supply of products in medical institutions in each city," he said. Collecting hidden line: medical insurance consumables code In the original "Draft of Comments", the purchase targets were blood glucose test strip products and infusion sets, syringes and pre-filled catheter irrigators that had been included in the "Liaoning Province Centralized Purchasing Network for Drugs and Medical Consumables" and obtained national medical insurance codes. In the final "Plan", there are only two purchase targets: infusion sets and pre-filled catheter irrigators that have obtained national medical insurance codes. "Because these two products have been covered by the national medical insurance code, this provides great convenience for centralized procurement," the person in charge explained, "The medical insurance consumables code is one item and one code. When reporting the historical purchase volume this time, we All procurement objects will be filtered out through the medical insurance code database of the National Medical Insurance Bureau. As long as medical institutions enter the national medical insurance code, they can immediately search for related products, which can be mapped one by one. For enterprises, when applying for participation in purchasing with volume When it comes to products, as long as there is a national medical insurance code, we will locate in detail which company and variety we want to participate in." He said that in the next step, experts will be organized to classify the two types of purchases with quantity, such as infusion sets, in detail. The two types of products will be specific to the specifications and models, and the purchase volume of each specification and model will be clearly stated. How to check the quality? It is mentioned in the selection method of the "Plan" that the evaluation team will vote on the declared products in turn based on the application documents and samples provided by the enterprise. Products with more than or equal to two-thirds of the total votes will enter the quotation link, and those with less than one-third of the total votes will enter the quotation process. The second product is eliminated directly. In this regard, he said that compared with high-value consumables, the threshold for low-value consumables is relatively low. In order to ensure the quality, we will let the manufacturer send samples by mail, and then organize experts to select the samples and check their quality. Pulling out the "nail": Solving the crux of payment collection On the issue of payment collection, Liaoning Province's "Plan" can be said to be firm. The "Plan" pointed out that this project adopts two methods of direct settlement of the medical insurance fund or prepaid payment. If the prepaid payment is adopted, the medical insurance agency shall prepay no less than 50% of the total purchase amount in the annual agreement of the medical and health institutions. For medical and health institutions, the payment for goods shall be settled before the end of the month following the delivery acceptance. In other words, there are two payment methods for this purchase with volume, direct medical insurance settlement or 50% prepayment settlement, and the settlement will be completed before the end of the next month. Medical institutions have become "supporting roles" in the payment relationship. "One amount and one payment must be guaranteed." The person in charge said that while requiring medical institutions to guarantee the amount, they must also guarantee the "payment". He introduced that because the settlement methods of each city are different, if direct medical insurance settlement is not adopted, the prepayment settlement method must be adopted. The medical insurance agency will allocate 50% of the funds to medical institutions before the implementation of the procurement cycle, and set up special It is specially used for purchasing with quantity to pay for the goods. "The implication is not to let the hospital default on the payment," he said. Is there a big difference in payment efficiency between the two methods? "Direct settlement will be faster. Because a company may target multiple hospitals, but no matter how many hospitals, the direct settlement of medical insurance will uniformly collect the payment of all hospitals into one and send it to the distribution company." He said that although the current level of progress varies from place to place, the direct settlement of medical insurance funds is the future direction. ?

In recent years, with the increasing awareness of people's health care and the continuous emergence of various new technologies, more and more medical device products have begun to enter the family, and the home medical device market has formed and developed rapidly, becoming a new growth point in the medical device industry. The definition is yet to be clarified The categories cover a wide range At present, in the current effective laws and regulations in my country, there is no clear regulation on how to classify household medical devices. The industry generally believes that household medical devices refer to medical devices such as general diagnosis, physical therapy, and hygiene materials that can be judged, purchased and used by consumers. By referring to the "Guidelines for Technical Review of Home In Vitro Diagnostic Medical Device Registration" published on the website of the State Food and Drug Administration in December 2020, the author believes that home medical devices can be defined as medical devices that can be used by non-professionals in non-medical environments. This description contains 3 elements: non-medical environment, which refers to uncontrolled general use environment outside medical institutions, such as home, school, office, outdoor (non-wild, relatively stable environment), public places, etc.; non-professional, refers to Ordinary users who have not been trained or certified, such as consumers who directly use the device, patients, patient family members, and general nursing staff (non-professional nurses); use is a general concept that does not only refer to active interactive behaviors (such as installation, setup, operation, etc.). , storage, carrying, cleaning, disinfection, replacement of accessories, troubleshooting, discarding, etc.), as well as passive interactive behaviors such as understanding display information and receiving reminders. According to relevant regulations and market conditions, the author divides household medical devices into the following categories: detection category, including blood pressure meters, blood glucose meters, electronic thermometers, etc.; treatment category, including household atomizers, magnetic therapy instruments, lumbar spine therapy instruments, etc.; Rehabilitation categories, including home oxygen concentrators, nursing beds, wheelchairs, etc.; health care categories, including massage pillows, massagers, nasal washes, etc.; in addition, infection control products (such as masks) that have been used on a large scale since the outbreak of COVID-19 , protective gloves, protective clothing, protective glasses, etc.), as well as physiological data collection wearable equipment, portable early screening equipment, portable dialysis equipment, blood glucose monitoring equipment, medical beauty products, etc.

Beijing, Tianjin, Liaoning, Shanghai, Jiangsu, Zhejiang, Shandong, Hubei, Guangdong (city) drug administrations, China Inspection Institute (device standard control center), device inspection center, Peking University School of Stomatology Oral Medical Device Testing Center : In order to implement the "Implementation Opinions on Comprehensively Strengthening the Construction of Drug Supervision Capacity" issued by the General Office of the State Council, and to implement the relevant requirements of the "14th Five-Year Plan for National Drug Development and Promotion of High-Quality Development", in accordance with the State Drug Administration for medical devices Industry standard formulation and revision work deployment, the 2022 medical device industry standard formulation and revision plan project is now issued to you, and the relevant requirements are notified as follows: 1. All relevant provincial (city) bureaus should attach great importance to them, conscientiously organize the standard undertaking units in their respective administrative regions to carry out standard formulation and revision work, strengthen supervision and management, and ensure that various tasks are completed as required. 2. The Device Standardization Center of the State Food and Drug Administration should conscientiously organize and coordinate various medical device standardization (sub) technical committees and technical focal points, and carry out standard formulation and revision work in strict accordance with the "Management Specifications for the Revision of Medical Device Standards" to strengthen business Management and inspection guidance to ensure standard quality and level. 3. Medical device standardization (sub) technical committees and technical focal points that undertake the task of standard formulation and revision should do a good job in organizing the drafting, verification, soliciting opinions and technical review of standards, and should conduct extensive research and in-depth research, and actively learn from international standards. Ensure the scientificity, rationality, applicability and compliance with relevant policy requirements of standard technical content. Attachment: 1. 2022 medical device mandatory industry standard formulation and revision plan project 2. 2022 medical device recommended industry standard formulation and revision plan project General Department of the State Food and Drug Administration

Drug Administration of all provinces, autonomous regions, municipalities directly under the Central Government and Xinjiang Production and Construction Corps: In order to implement the relevant requirements of the "Drug Administration Law", "Measures for the Administration of Drug Registration" and "Measures for the Supervision and Administration of Drug Production", and to further guide the holders of drug marketing authorizations (hereinafter referred to as holders) to establish an annual reporting system, the National Medical Products Administration The Bureau organized the formulation of the "Regulations on the Administration of Drug Annual Reports" (see Annex 1) and the "Template of Drug Annual Reports" (see Annex 2), which are hereby issued. At the same time, in order to ensure the implementation of the drug annual report system, the State Food and Drug Administration has built a drug annual report collection module, which will be activated at the same time. The relevant matters are hereby notified as follows: 1. Urge the holder to implement the main responsibility of the annual drug report The annual drug report system is a new system proposed by the Drug Administration Law. The "Drug Administration Law" clearly stipulates that drug marketing license holders shall establish an annual reporting system, and report the production and sales, post-marketing research, risk management, etc. of drugs to the drug regulatory department of the people's government of the province, autonomous region, and municipality directly under the Central Government every year. The holder of the annual report shall be the holder; if the holder is an overseas enterprise, the legal person of the enterprise that is legally authorized and bears joint and several liability within the territory of China shall perform the obligation of the annual report. Provincial drug regulatory authorities should strengthen policy publicity, supervision and guidance, and further urge holders to implement the main responsibility for quality management throughout the process by regulating holders' annual reporting behavior. Holders should take the annual report as a starting point to enhance their awareness of subject responsibility, give full play to their subjective initiative, and further improve their own management level. The holder shall appoint a special person to be responsible for the annual report, improve the internal report management system, strictly review and check the content of the annual report, and ensure that the information filled in is true, accurate, complete and traceable. 2. Effectively do a good job in data sharing and information application The State Food and Drug Administration has built a drug annual report collection module. In order to facilitate the holder to fill in the report, this module directly connects to the drug registration, drug production license and other relevant information of the drug regulatory data sharing platform, and realizes the automatic transmission of key basic information, which helps to improve the accuracy of the filling information. In the follow-up, it will give full play to the advantages of the national drug supervision data sharing platform, and gradually collect the annual report information into the drug variety file and drug ** credit file respectively, and consolidate the information foundation for smart drug supervision. All provincial drug regulatory authorities should use the annual report information as a reference material and research basis for supervision and inspection, risk assessment, credit supervision and other work, and gradually realize comprehensive and scientific supervision, and improve the supervision efficiency of the whole life cycle of drugs. At the same time, in combination with supervision and inspection and other work arrangements, the content of the holder's annual report will be reviewed, and the holder who does not submit the annual report as required will be investigated and punished according to law, and it will be included in the drug ** credit file. 3. Make every effort to do a good job in the operation and maintenance of the annual report collection moduleThe drug annual report collection module is divided into the enterprise side and the regulatory side. The information collected by the enterprise includes two aspects: the public part and the product part. Among them, the public part includes the information of the holder, the overall situation of the products held, the overview of quality management, the construction and operation of the pharmacovigilance system, the acceptance of overseas commissioned processing, and the acceptance of inspections by overseas drug regulatory agencies; the product part includes Product basic information, production and sales, post-market research and change management, and risk management. After the holder completes and submits the annual drug report, the provincial drug regulatory department can view the information of the holder's annual drug report within the administrative area through the regulatory terminal. The information center of the State Food and Drug Administration should do a good job in technical support after the module goes online. Please refer to the operation manual (see appendix 3 and appendix 4) for the authorization and operation procedures of the enterprise side and the supervisor side. **New electronic version of the operation manual can be downloaded from the system. If problems are found during the use of the system, users can contact the technical support customer service hotline (4006676909 to 2) at any time; they can also communicate by joining the QQ work group (supervisory users: 320404770; enterprise users: 282253676). 4. Other matters 1. These regulations will come into force from the date of promulgation, and the drug annual report collection module will be activated at the same time. 2. In view of the implementation of the annual drug report system in my country, the drug annual report collection module is still in the trial operation stage, and the deadline for filling in the 2021 annual report information is August 31, 2022; starting from next year, fill in the report before April 30 every year Annual report information. Annex: 1. Regulations on the Administration of Annual Reports of Drugs 2. Template for the Administration of Drug Annual Reports (2022 Edition) 3. Enterprise-side operation manual of drug annual report collection module 4. Operation Manual for the Supervisory Terminal of the Collection Module of the Drug Annual Report State Food and Drug Administration

China Consumer News Beijing News (Reporter Sun Yanming) A few days ago, the 2022 China Medical Development Conference hosted by the Chinese Academy of Medical Sciences was held in Beijing. Experts at the meeting conducted in-depth discussions on the development and innovation of clinical medicine, stomatology, basic medicine and biology, pharmacy, health and environment, biomedical engineering and informatics, pharmaceutical industry transformation and medical history, so as to further distinguish Opportunities and challenges, build consensus on development, further clarify the connotation of scientific and technological strength of the national medical and health strategy, explore the construction path, and put forward strategies and policy suggestions for the high-quality development of medical and health care. At the meeting, the Chinese Academy of Medical Sciences released "China's Important Medical Achievements in the 21st Century" and "China's Important Medical Progress in 2021". "China's Important Medical Achievements in the 21st Century" focuses on important medical and health achievements that have significant scientific, technological, economic, social, and cultural values in my country since 2000, and are highly recognized by peers. A total of 4 achievements were selected into "China's Important Medical Achievements in the 21st Century", namely "Basic Research and Clinical Transformation of Langerhans Cell Biological Function" completed by the First Affiliated Hospital of China Medical University, which significantly promoted the development of immunobiology. It provides a theoretical basis for the treatment of organ transplantation and infectious skin diseases, and opens up a new direction for the treatment of tumors and viral infectious diseases; the "China Blood Purification Medical Quality Management and Control System Creation, Implementation and Control System" completed by the People's Liberation Army General Hospital. "Leading" has improved the level of blood purification diagnosis and treatment and medical quality control in China; the "Molecular Genetics Research and Clinical Application of Spinal Deformities" completed by Peking Union Medical College Hospital and Fudan University has promoted the screening, prevention, diagnosis and treatment of spinal deformities in my country The standardization and homogenization of human germ cells and embryonic development were completed by Peking University Third Hospital and the Biomedical Frontier Innovation Center of Peking University School of Life Sciences. "Through-through sequencing single-gene genetic disease and chromosomal abnormalities screening test-tube babies" has improved the treatment success rate of difficult infertility patients, and made my country's embryo preimplantation genetic diagnosis technology reach the world's leading level. "China's Important Medical Progress in 2021" focuses on the medical science and technology progress projects produced in the year that have certain academic and social influence, promote the development of disciplines, improve the practice of "promoting prevention, diagnosis, control and treatment", and promote the potential of health industry progress. A total of 31 projects were selected, including the [Establishment of Blood Pressure Control Targets for Elderly Hypertensive Patients" completed by Fuwai Hospital of the Chinese Academy of Medical Sciences, and the [Discovering New Coronary Pneumonia Recovered Patients" completed by China-Japan Friendship Hospital, Wuhan Jinyintan Hospital and other units. Long-term clinical outcomes and risk factors" project, and the project [Discovering that PD-1 antibody combined with chemotherapy can significantly prolong the survival time of patients with advanced esophageal squamous cell carcinoma" completed by Sun Yat-sen University Cancer Center and other units. Academician Wang Chen, vice president of the Chinese Academy of Engineering and president of the Chinese Academy of Medical Sciences, pointed out in the keynote report "Building National Medical and Health Strategic Science and Technology Power" that the 21st century is the century of medicine and life sciences, and the cause of medical and health care is related to national security and economy. development, social civilization and people's well-being. At present, my country's medical and health science and technology innovation has problems such as "insufficient quantity, high quality, fragmentation, and imbalance". It is urgent to build an advanced, guiding, backbone and decisive feature that can reflect the national will, A national strategic scientific and technological force that serves national needs and represents the highest level of national scientific and technological innovation. Wang Chen suggested that we should continue to strengthen the integration and optimization of the allocation of scientific and technological resources, strengthen original and leading scientific and technological research, persevere in basic research, and vigorously build major scientific and technological innovation platforms, so as to achieve my country's achievements with complete systems, sufficient resources, advanced platforms and ecology. The boom in medical technology. It is necessary to pay special attention to the construction of the national clinical medical research system, set up special funds to support national clinical research, build a specialist clinical research network, formulate a clinical data standard system, establish a high-quality clinical talent training system, and improve the research doctor's career development incentive system. Fundamentally To change the current situation of insufficient investment in clinical medicine, incomplete national clinical research network, lack of scientific and technological talents in clinical medicine, and low output of high-quality and high-level clinical research. In the process of promoting the construction of a national medical and health strategic scientific and technological force, it is urgent to set up a special national medical and health science fund, build a national academy of medical sciences representing the national level, and continuously improve the national medical strategic scientific and technological talent system.

Medical and Health Information Medical device news, bringing together the latest pharmaceutical policy R&D business trends, authoritative data reports, cutting-edge technologies, industry high-end interviews, pharmaceutical exhibitions, in-depth reports, etc., to take you to understand the development trend of China's medical industry and the latest news news, the latest medical information The news source network is organized, and you can read it below for what you need to know. Medical device news, latest medical information news: On February 21, 2022, "Heavy Nuclear Drugs Approved! Can You Help Domestic Nuclear Drug Innovation Press the "Nuclear Button"?" Telix and the German ITM company have gradually built an international first-class nuclear drug diagnosis and treatment platform in the field of anti-tumor, and have realized a full industrial chain in the global nuclear drug field, including research and development, production, sales, regulatory qualifications and other fields. layout. Prior to this, China Tongfu and Dongcheng Pharmaceuticals had long occupied the dominant position in the domestic nuclear drug market, with many approved products and large market shares. In the foreseeable future, my country's nuclear medicine field will become more and more lively. "2022 New Bureau of Medical Insurance Collection and Exhibition", in 2022, the National Medical Insurance Bureau will guide local governments to follow clinical needs, focusing on large varieties and common diseases, to check and fill gaps to promote centralized purchases, and strive to achieve provincial-level centralized purchase varieties carried out in each province. More than 100, high-value medical consumables can cover 5 varieties. In the past three years, the state has organized centralized procurement to carry out precise "targeted therapy" for drugs and consumables with large clinical doses and inflated prices. While solving the problems of difficult and expensive medication for patients, it also has a positive "catfish effect" on the development of the pharmaceutical industry. . The second-class medical equipment of the gout immunology department - gout physiotherapy cabin + medical equipment cold compress gel + traditional Chinese medicine Shuangjiang tea, targeted to solve sub-health problems. [Special Medical Technology Gout Physiotherapy Center], has a good acid-lowering effect, analgesia and crystals, and improves immune metabolism. [Special Medical Technology Gout Physiotherapy Center]Specific far-infrared electromagnetic wave gout cabin, second-class medical equipment can be used in hospitals, health care bases, health care places, beauty and beauty industries, etc. [Special Medical Technology Gout Physiotherapy Center] provides technical support for the output of the whole store, duplication of the operation model, guidance and cooperation from specialists when they go to the store, and online advertising to support the proportion of advertising reimbursement and other advantages. It has cooperated with typical customers [Zhejiang Meidigang Medical] [Shanghai Huayou Health Management] [Qingdao Kangyang Town] [Weinan City New Lansi Beauty and Health Center] and so on. Medical News, China Medical News Network: On February 21, 2022, the "Technical Guidelines for Clinical Trials of New Antiviral Drugs for Novel Coronavirus Pneumonia (Trial)" was released to guide the scientific research and development and evaluation of antiviral drugs for Novel Coronavirus Pneumonia. Reference technical standards. On February 21, "Making millions of "high-priced drugs" close to the people is the key to breaking the situation in cell therapy. In 2021, the State Food and Drug Administration of China approved the launch of two CAR-T immune cell therapies, opening the door to the era of cell therapy in my country. New Years. On February 22, "Free vaccination is implemented, high-priced HPV vaccine will be completely reduced to "chicken ribs". At present, it seems that if the government's free HPV vaccination program continues to be implemented, then high-priced vaccines such as 11-valent and 14-valent vaccines will be lost in the future. The vast majority of the market, even decades later, is completely useless. On February 22, "Kexing Pharmaceuticals and Antaiwei Co-Developed Oral Drugs Against New Coronavirus". At present, a number of new crown oral drugs have been approved for marketing and emergency use around the world, and domestic new crown oral drugs have also repeatedly made new progress. Xing Pharmaceutical Co., Ltd. to develop oral anti-coronavirus drugs. Medical device news, the latest medical information news: On February 21, 2022, "the websites of 13 illegal social organizations including China Medical Industry Alliance were shut down", the Ministry of Civil Affairs, together with relevant departments, recently shut down the first batch of 13 in 2022. Websites of illegal social organizations and related new media accounts. On February 22, the four departments jointly issued a document to promote mutual recognition of inspection and test results in medical institutions. According to the principle of [standards for the judgment of doctors", the mutual recognition of inspection and test results shall be carried out. On February 21, "Mainland Aid Hong Kong Anti-epidemic Medical and Epidemic Prevention Team Extends Visit to Hong Kong", ""Data Intelligence" Breaks the Dilemma of Traditional Medical Model, Metaverse Medical Alliance was founded in Shanghai", "Hainan Free Trade Port Digital Medical Health Ecological Conference was held" The first "Digital Healthcare Innovation Base" in the Free Trade Port was officially unveiled." On February 14, "Genetic testing fraud is never a secret in the industry", genetic testing fraud, whether it involves defrauding medical insurance funds, has never been a secret in the industry, and the AstraZeneca incident is by no means an exception. Medical news, the latest medical information news: "Joan Medical iHealth debuted in the US "Super Bowl" on February 14, "the world's first country announces the end of the epidemic" on February 15, Sweden officially announced in the early morning of February 9, Beijing time : From now on, the new crown virus will no longer be regarded as a major social hazard, and the Swedish government will also lift the remaining restrictions, including the termination of large-scale new crown virus testing, becoming the first country in the world to declare the end of the epidemic. On February 15, "National Health and Health Commission: Will Improve "Internet +" Medical Service Prices and Medical Insurance Payment Policies", on February 21, "National Health and Health Commission Publishes Assessment Indicators, Involving All Medical Institutions", National Health and Health Commission issued " The Notice on the Implementation Plan for the 2021-2022 Assessment of the Healthy China Action", which focuses on the main objectives and tasks of the healthy China construction and the overall goals of the Healthy China Action, combined with the 2019-2020 Healthy China Action Test Assessment, has formulated a series of targeted and oriented Sexual assessment indicators. The development trend of China's medical industry and the latest information and news trends, the latest medical information news related collation and introduction are here, and more medical news information can be learned online.

Last week, a mutant strain of Omicron spread widely around the world. According to data from Johns Hopkins University in the United States, as of the 13th, at least 49,749,157 people have been diagnosed worldwide. There have been many local clustered outbreaks in China. There have been about 4,000 new infections in Hong Kong in the past two weeks. The University of Hong Kong estimates that the epidemic will peak in March, and it is recommended to close the city. In the field of vaccines and drugs related to the new crown, the Food and Drug Administration approved Pfizer's new crown virus treatment drug to be listed with conditions; Eli Lilly's new crown neutralizing antibody Bebtelovimab obtained the FDA's emergency use authorization and reached a purchase order of 720 million US dollars; due to the rapid changes in the epidemic situation, AstraZeneca announced to abandon the new crown vaccine for the beta variant... In terms of policy, the Health and Health Commission has made major adjustments: the CDC and the Comprehensive Supervision Bureau have been revoked, the Medical Administration and Hospital Administration has been renamed the Medical Administration Department, and the Health Emergency Office has been renamed the Medical Emergency Department; the State Information Office has held a regular policy briefing, emphasizing " Centralized procurement does not pursue the lowest price, and also firmly opposes running bidding"- In terms of personnel changes, Ben Yong, chief medical officer of BeiGene Immuno-Oncology, resigned, and Mark C. Lanasa, the former global clinical head of late-stage development of AstraZeneca Oncology, took over.

In 2021, as the first year of the 14th Five-Year Plan, the medical and health care industry, known as the "never-declining sunrise industry", is shrouded in shadows. Especially in the secondary market, the stock price has been cut in half, the listing has broken, and the IPO has been rejected or postponed. With the frequent news, people can't help but worry about the future development of the medical and health industry. In fact, the rigid demand nature of the industry has not changed. In the past few years, driven by capital, industry innovation has been vigorous, but it has also led to the emergence of an IPO-oriented crash model. Next, the development of the industry will enter a rational stage and return to a basic value position: its professional barriers are extremely high, and it is greatly affected by policy supervision. . However, the "Chaoyang Industry" is still the "Chaoyang Industry", especially with the accelerated aging of the population, the improvement of national health awareness stimulated by the epidemic, and the guarantee of new technologies and policy support, the development of the industry may experience some transition pains. However, the general direction of the bow has not changed, and opportunities for industrial development are still emerging. Against this background, Yiou Think Tank has sorted out the top ten trends in the development of the medical and health industry by summarizing the outlook for industry professionals and Committed to providing some references for cross-border people who are upgrading national health. 1. The future development trend of medical digitalization. The development trend of digital therapy: the data algorithm service model will bring about an innovative ecology, and the industrial role based on data needs to be supplemented and improved. The future trend of smart hospitals: Hospitals are developing rapidly from "informatization" to "digital intelligence", and the underlying data is gradually improving. The future trend of clinical digitalization: establishing standards and establishing an intelligent and diversified business model with the participation of multiple parties. The development trend of digitalization of pharmaceutical marketing: from the patient side, the doctor side, and the pharmacy side, to create a closed loop of data and achieve precise marketing. AI pharmaceutical development trend: More and more people are calculating the only way for pharmaceutical companies to move from service to independent research and development pipeline. The development trend of artificial intelligence medical imaging: the industry standard is being established, and the future product commercial space will be explored towards service and whole course management. The development trend of the medical metaverse: establishing the connection between the real and the virtual world, and finally realizing the medical metaverse, which will generate huge value. 2. The future development trend of rehabilitation medicine. Policies once again boosted the development of rehabilitation medicine, thereby alleviating the pressure on medical insurance funds and optimizing the allocation of medical resources. The pilot program is first, focusing on public medical care, and accelerating the replenishment of rehabilitation medical resources; social capital intervenes to supplement high-end demand. As the demand for rehabilitation equipment increases, enterprises will improve their competitiveness through continuous innovation. Among them, the development of rehabilitation robots is expected to accelerate. 3. The future development trend of innovative payment.

1. Policy trends 14 Henan Province Alliance Centralized Procurement: Medical institutions begin to confirm the amount to be distributed On the 14th, the Shanxi Provincial Pharmaceutical Equipment Centralized Bidding Procurement Network issued the "Notice on Carrying out the Confirmation of the Collective Procurement of the Selected Varieties in the Fourteen Provinces (Autonomous Regions, Municipalities, and Corps) Drug Alliances to Be Distributed". Fill in the selected drugs with the lowest price in Groups A and B, and 50% of the amount to be allocated by the medical institution for this variety will be allocated to the lowest-priced drugs. If there is unallocated content to be allocated, it will be uniformly allocated to the lowest price selected company. In addition, in order to solve the problem of conversion between different specifications in the weighting process, the weighting is carried out according to the content data. The content data is the pre-purchased quantity (tablet/grain/bag/stick) filled in by the medical institution multiplied by the content value (by the variety Specifications) can be calculated, for example: Hospital A fills in 100 tablets of atenolol of 25mg, and the content data is converted to: 100 (pre-purchased amount) * 25 (content value) = 2500mg. 2. Approval of medical devices ●The State Food and Drug Administration approved the registration of 198 medical device products in February On the 14th, the State Food and Drug Administration issued an announcement on the approval and registration of 198 medical device products. In February 2022, the State Drug Administration approved a total of 198 registered medical device products. Among them, there are 137 domestic third-class medical device products, 36 imported third-class medical device products, 22 imported second-class medical device products, and 3 Hong Kong, Macao and Taiwan medical device products. ● InnoCare BTK inhibitor new indications apply for listing On the 14th, Nuocheng Jianhua announced that the NMPA Center for Drug Evaluation has accepted the new indication marketing application of its BTK inhibitor orelabrutinib for the treatment of patients with relapsed/refractory Waldenström macroglobulinemia. 3. Capital Market ● Yilian Bio completed $70 million in Series B financing Recently, Yilian Bio completed a $70 million Series B financing. This round of financing was led by Zhouling Capital, jointly led by Qiming Ventures, and followed by Legend Capital, Zhengxingu Capital and Honghui Fund. The funds raised in this round of financing will be mainly used for the clinical trial development of the company's next-generation antibody conjugated drug product pipeline, as well as the early research and development of new conjugated drugs. ●Yuesai Bio completed nearly 200 million yuan of Pre-A round of financing On the 14th, Yuesai Bio announced the completion of nearly 200 million yuan in financing. This round of financing was led by Sherpa Investment, co-led by CDH VGC (Innovation and Growth Fund), and jointly invested by Taifu Capital, Kunlun Capital, Hillhouse Ventures, Fosun Pharma, Ruihua Capital and Guofang Capital. This round of financing will be mainly used for the R&D investment of multiple pipelines, the construction of clinical-grade cell product production plants, and the initiation and promotion of related clinical trials. ●Ricco Bio has passed the hearing of the Hong Kong Stock Exchange On March 14, Jiangsu Ruike Biotechnology Co., Ltd. passed the hearing of the Hong Kong Stock Exchange. According to the data, it is a vaccine company founded in 2012, dedicated to the research and development and commercialization of subunit vaccines. The company mainly focuses on the research and development of HPV vaccine candidates. The company has established a vaccine portfolio consisting of 12 vaccine candidates, including the company's core product REC603, a recombinant HPV nine-valent vaccine for cervical cancer prevention, which is currently in Phase III clinical trials. For the years ended December 31, 2019 and 2020 and the nine months ended September 30, 2021, the company's total comprehensive losses for the year/period were RMB 138 million, RMB 179 million and RMB 520 million, respectively; the corresponding R&D The costs were 63.265 million yuan, 131 million yuan and 372 million yuan respectively. Fourth, industry events ●Berry Gene released products that can screen 153 kinds of genetic diseases On March 14th, Berry Gene released the expanded carrier screening (standard version) with Xinan, which is based on the latest "Guidelines" of ACMG (American Society for Medical Genetics and Genomics), focusing on the types of genetic diseases that meet the characteristics of the Chinese population , more in line with China's clinical needs, and the test results are more accurate and comprehensive. This new product release will further improve Berry Gene's reproductive health product matrix, provide better protection for couples during pregnancy, early pregnancy, and assisted reproductive populations, and help prenatal and postnatal care. Carrying Xinan Extended Carrier Screening (Standard Edition) refers to the latest ACMG "Guidelines" to include genes, and at the same time fully considers the carrier rate of Chinese and Asian populations to adjust, and finally includes 129 genes and 153 genetic diseases for screening, covering Metabolic endocrine, nervous system and neuromuscular disease, respiratory, audio-visual and other systems better meet the clinical needs, so that the disease can be selected into science. 1 Drug.com and BGI have reached a new crown antigen detection kit cooperation On March 14, the digital medicine and health platform 1 Yaowang (Nasdaq: YI) reached a strategic cooperation with Shenzhen Huada Gene (300676) Co., Ltd. The latter's novel coronavirus (2019-nCoV) antigen detection kit (fluorescence immunoassay) Chromatography) will be supplied to the whole country through the 1 Drug Network digital platform, quickly covering the population in demand, and helping the national epidemic prevention and control. Among the 8 companies that signed a strategic cooperation framework agreement in the same period, 1Pharmaceutical.com, as the only online platform, will become the first online retail platform for BGI's new coronavirus antigen detection kit. Since it will take some time for the new crown antigen detection kit to be purchased and put on the shelves, 1 Drug Network will start product pre-sale within this week. Obama tests positive for coronavirus According to Xinhua News Agency, former US President Barack Obama said on the 13th that he tested positive for the new crown virus. Obama posted on social media that day that he recently felt a sore throat, but otherwise felt fine. Both he and his wife, Michelle, have completed the new crown vaccination and received a booster shot. Michelle tested negative for the coronavirus. Obama was born in 1961 and served as President of the United States from 2009 to 2017. Statistics on the new crown epidemic released by Johns Hopkins University in the United States show that as of the 13th, the cumulative number of confirmed cases of new crown in the United States has exceeded 79.5 million, and the number of deaths is close to 970,000.