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01 Level II and above designated medical institutions, the All included in the scope of DRG actual payment Recently, the Beijing Municipal Medical Insurance Bureau issued the "Notice on the Issuance of the Key Work of Medical Security in Beijing in 2023" (hereinafter referred to as the "Notice"). The Notice points out that it is necessary to continue to deepen the reform of multiple and compound medical insurance payment methods. Inpatient speed up and expand the implementation of DRG payment, and include all eligible secondary and above designated medical institutions in the city in the actual payment scope. Improve the new drug and technology and special case exclusion mechanism, and deepen the DRG payment and the linkage management of the quantity procurement policy. Study the pilot implementation of outpatient capitation payment for chronic diseases such as diabetes and hypertension in some of the closely-knit medical associations. Continuously optimize the new model of total medical insurance budget management. Improve the total budget management (BJ-GBI) cost budget clearing mechanism, strengthen BJ-GBI quality evaluation, and play the role of quality-centered health insurance value payment. Make effective connection with DRG payment, capitation payment and other payment methods, and make efficient linkage with centralized procurement, national negotiation drug and other policies. Improve intelligent supervision, promote intelligent audit and monitoring of DRG and other payment methods reform, and explore intelligent audit and monitoring of long-term care insurance in due course. Currently, the national DRG/DIP payment reform is in full swing, and some pilot regions have completed the tasks related to the three-year action plan ahead of schedule. The Guangdong Provincial Medical Insurance Bureau issued a document last year stating that six pilot cities, including Guangzhou, Shenzhen, Zhuhai, Shantou, Foshan and Heyuan, have completed the national DIP and DRG pilot tasks, and on the basis of the continuous consolidation of the reform results in the pilot cities launched in advance, all the remaining cities will carry out DIP payment reform in 2022, which will achieve full coverage two years ahead of schedule. The Hebei Provincial Medical Insurance Bureau studied and issued the "Hebei Province DRG/DIP Payment Method Reform Three-Year Action Promotion Plan", which plans to achieve full coverage in all coordinating districts in the province by the end of 2022 and full coverage in designated medical institutions carrying out inpatient services by the end of 2023, completing the national reform tasks one year ahead of schedule. The Implementation Plan for the Three-Year Action Plan for DRG/DIP Payment Reform in Shanghai (2022-2024) proposes to achieve DRG/DIP payment health insurance fund spending of 70% of inpatient health insurance fund spending in 2022, completing the national health insurance fund full coverage task two years ahead of schedule. Simultaneous exploration of DRG/DIP payment for residents' basic medical insurance, feasibility study in 2022, pilot in 2023 and promotion on the surface in 2024. According to the "Notice on the Issuance of Three-Year Action Plan for DRG/DIP Payment Reform" previously issued by the National Health Insurance Bureau. By the end of 2024, all the co-ordinated areas in the country will carry out the DRG/DIP payment reform, and the pilot areas will continue to consolidate the reform results; by the end of 2025, the DRG/DIP payment method will cover all eligible medical institutions that carry out inpatient services, and basically achieve full coverage of disease types and medical insurance funds. 02 Innovative devices, leaving a "three-year" time window Under the DRG/DIP payment reform, drugs and consumables have changed from profit items to cost items for hospitals. With the abrupt change of hospital development model, the development of new drugs and technologies has become a part that needs special attention. In July last year, the Beijing Municipal Medical Insurance Bureau issued the "Notice on the Issuance of Management Measures for Payment Exclusion of New Drugs and New Technologies for CHS-DRG Payment (Trial)", deciding to implement the management measures for payment exclusion of new drugs and new technologies for CHS-DRG payment on a trial basis. According to the pilot scheme, drugs and medical devices need to meet the requirements of "new generic drugs/medical devices approved by the drug regulatory authority within three years (including the year of declaration and the two natural years before, the same below); drugs with significant changes in function or indications within three years; drugs newly included in the national medical insurance drug list within three years; new medical devices that can be charged separately due to price adjustment within three years. New medical devices that can be charged separately", "clinical effect has been greatly improved compared with traditional drugs/medical devices", "the cumulative cases of basic medical insurance participants in the city reached more than 50 cases, rare diseases are not limited by the number of cases " and other restrictive conditions. Despite the rather strict reporting conditions, the introduction of the excluded payment policy still opened the window for innovative products, which became the focus of attention for a while. In March of this year, the National Health Insurance Bureau made public the "Response to Proposal No. 3298 of the Fifth Session of the 13th National People's Congress", which affirmed the CHS-DRG payment support mechanism related to new medical technologies explored by local health insurance departments in Beijing and Hebei Handan during the pilot work. It is understood that Hebei Handan has clarified that groups of diseases with abnormally high and abnormally low values of payment can be paid by items, and the list of special treatments and special drugs, and high-value consumables can be excluded from the DRG grouping to ensure full coverage. In addition to the above-mentioned areas, Foshan, Xuzhou, Sanming, Hangzhou, Rizhao and many other places have also introduced relevant initiatives to explore special payment policy support programs. For example, Hangzhou provides additional compensation to pilot hospitals in cases where the cost of individual cases is higher than the average cost of the patient group due to da Vinci robotic surgery, TAVI, femtosecond, TOMO and other items. Foshan and Xuzhou implemented waiver payments for very high cost cases as well as special needs services; Sanming implemented an exclusion list system for some medical consumables. According to the National Health Insurance Bureau's "National Health Insurance Diagnosis-related Grouping (CHS-DRG) Technical Specification for Grouping and Payment". For the new technology items that have been filed in the medical insurance office, the technical specifications clarify that the implementation of the project payment can be temporarily implemented for one year, and then according to the data to measure and revise the payment standards for the disease grouping. For difficult and serious diseases, the technical specifications specify that the weight value of the DRG group for difficult and serious diseases can be increased, and the weight value of the DRG group for minor diseases can be reduced. Along with the continuous improvement of DRG/DIP payment supporting measures, will there be more new drugs, new technologies and innovative devices support mechanisms?

Exhibitors of technology companies - "The new high-tech products successfully attracted the attention of many overseas businessmen" "In business, there is a saying that 'one meeting is better than a thousand emails'. In fact, for us equipment manufacturers, there is another saying, 'a hands-on practice is better than a hundred pictures'." Shi Zaiqing, deputy general manager of Nakazaki Commercial Machinery Co., after making a phone call with his colleague to coordinate the factory visit time, while making a record in his cell phone memo, said to the reporter, "One of the biggest gains of participating in the Canton Fair this time is to be able to communicate with customers on site about the experience of using products, and even invite them to visit the factory for hands-on practice. " Zhongqi is a national "small giant" enterprise providing product design, R&D, production, sales and specialized technical services for intelligent terminals. As the deputy general manager in charge of research and development, Shi Zaiqing is most concerned about how to make the design and development closer to customer needs: "Only when the customer gets the sample that is the moment the answer is revealed." The process of waiting for an answer is tangled, and the response is not always ideal. "Once, a customer proposed a modification to a prototype of a commercial cash register shipped to Europe, saying that 'the anti-theft function is too simple and a snap needs to be added'. Just for this snap and the smoothness of opening and closing, we modified the prototype twice, which took more than two months before and after." Shi Zaiqing said that nowadays, for the texture of the product, the fineness and smoothness during use, customers can verify it in the factory workshop, "which greatly improves the communication efficiency and optimizes the production process." For Li Weijie, manager of the foreign trade department of Nakazaki Corporation, he has been busy before the opening of this Canton Fair. "Many old online customers sent their product requirements in advance, hoping we could make samples and bring them to the exhibition site for experience." Li Weijie said that with the pre-preparation time, these customized demands can be transformed into the unique advantages of our own products, and thus win the praise of customers. "This exhibition is also a great opportunity for us to introduce new products." Li Weijie pointed to a flat, shaped like a vegetable market weighing table products, said, this is the company launched a new generation of checkout scales using artificial intelligence technology, similar new products are also wise selection of meal scales, "With the Internet of Things, artificial intelligence technology application scenarios are increasingly rich, this exhibition, such high-tech new products successfully attract the attention of many overseas businessmen, which is also This is an important starting point for us to develop overseas markets in the future." "From the first time we participated in Canton Fair in 2006 to now, we have gained a lot even when we participated in online Canton Fair during the epidemic. This time the preliminary communication has ended, the customer's willingness to cooperate is obvious, and we are confident to get more orders." While talking, another phone call came in, and Shi Zaiqing put in a new round of busy communication. Large overseas purchasers - "The new products and technologies in the field of smart home, intelligent manufacturing, etc. were focused on understanding" In the Canton Fair, buyers do not have booths, but as a large overseas buyer, Changyou Group from Indonesia still has a fixed rest area. "This is already my third time in China this year." Sitting in the rest area, Zhu Zhiwei, purchasing director of Changyou Group, said that he came to China first after the Chinese New Year. "We have to seize the time to strengthen cooperation with Chinese suppliers and eliminate the impact of the epidemic as soon as possible." "These days, many long-term partners are coming over to take a look. We haven't seen each other for several years, so let's meet and chat about new business." Zhu introduced that since this year, the company's incoming shipments in China have picked up rapidly and have now reached about 2,500 containers per month. In Zhu's view, the resumption of smooth trade so quickly stems in large part from the foundation of previous cooperation. "During the epidemic, our demand for Chinese products was undiminished, but sourcing became difficult all of a sudden." Zhu said that since 2020, the Canton Fair organizer will regularly communicate with Changyou Group and hold online matchmaking meetings to recommend suppliers in a targeted manner. "Three years down the line, large and small online supply and demand docking sessions opened more than 20, the Canton Fair for us to carefully selected more than 500 potential suppliers. The suppliers on the list are very strong, and finally, we have reached a deal with more than 50 of them." "Whether it's building an online platform or organizing offline exhibitions, Canton Fair can let us overseas buyers feel at ease 'buy buy buy'." Zhu Zhiwei said. "In the first phase of this year's Canton Fair, Changyou Group had 30 buyers scattered in various venues, focusing on new products and technologies in areas such as smart home and intelligent manufacturing, in addition to purchasing traditional goods." Zhu Zhiwei told reporters. "Attending the offline Canton Fair again after 3 years, some new products and technologies have inspired us a lot." Pointing to a brochure of mobile energy storage power supply, Zhu said that this kind of product is relatively rare in Indonesia at present, but it is very much in line with the development trend of family outing for leisure and entertainment. In his opinion, cooperation between buyers and suppliers can break through the traditional single form of trade. "This kind of cooperation based on mutual understanding is more efficient and effective." The small rest area was crowded with people coming and going, as crowded as a very popular booth. "With more goods and more people, the familiar Canton Fair is back, and more Made in China will enter Indonesia from here." Zhu Zhiwei said. Integrated foreign trade service provider - "One-stop service, so that the original single-player foreign trade enterprises, in the international market has a stronger bargaining power" When I met Ying Xiuzhen, she was walking through the Canton Fair Hall: "It's quite good to put these refrigerators in a row." "You have a few customers to visit this morning, how do you feel?" Ying Xiuzhen is the general manager of Zhejiang Ningbo foreign trade comprehensive service platform - Zhongji Huitong. "Only the first phase of the Canton Fair, we have secured more than 40 booths for the foreign trade enterprises on the platform." As 30 consecutive years of participation in the "old Canton Fair", when it comes to the Canton Fair, Ying Xiuzhen glowing: "For foreign trade enterprises, the Canton Fair is like a big test, how competitive products, customer recognition, are here to test the water." "Where the needs of foreign trade enterprises, where we are. The value of foreign trade comprehensive service platform is to release the maximum vitality of small and medium-sized foreign trade enterprises." Long-term cultivation of foreign trade industry, should show Jane know that small and medium-sized micro enterprises export is not easy. "When many foreign trade enterprises and related service parties are introduced to an open and shared digital platform, there is a supply chain advantage." Ying Xiuzhen cited the example that financing is a pain point for small and medium-sized foreign trade enterprises, but when products, logistics, sales and other business operations are traceable online, the data generates value, according to which banks introduced on the platform can provide unsecured low-interest credit loans for small and medium-sized enterprises. "Nowadays, Centric Huitong provides one-stop services such as customs clearance, settlement, export credit insurance, logistics, tax rebates and financing for more than 10,000 small and medium-sized micro and foreign trade enterprises, giving foreign trade enterprises, which were originally fighting alone, stronger bargaining power in the international market." Ying Xiuzhen said. Can go out is not enough, more to go far, Ying Xiuzhen see it clearly. "The international market competition is fierce, Chinese manufacturing to stand firm, we must do everything possible to enhance the stickiness of demand in overseas markets." How to do? "Build a global marketing system that integrates online and offline." In last year's Canton Fair on the Cloud, CKI Huitong has applied augmented reality and virtual reality technologies to the online pavilion. "Highly restored reality pavilion, naked eye 3D real-time communication and interaction, the application of new technologies has greatly enhanced the intelligence and interactivity of the online pavilion." Ying Xiuzhen introduced. Offline physical exhibition has been restored, spending large costs to build online pavilion is still necessary? "The physical exhibition contact is trust and feelings, online exhibition to provide a large amount of information, online and offline together, why worry about not into the heart of the business?" Ying Xiuzhen said. Offline exhibition curator - "Through the new exhibition area, we have a higher order conversion rate and customer stability" In the past few days since its launch, Jiang Yiyu, an employee of the Canton Fair Work Division of China Foreign Trade Center, has been going around in the industrial automation and intelligent manufacturing exhibition area, asking from time to time about the communication between exhibitors and buyers. As a recruiter of the first phase of the Canton Fair industrial automation and intelligent manufacturing exhibition area, Jiang Yiyu saw a steady stream of buyers who stopped from time to time to consult in detail with the booth staff, while lamenting that the work of the past few months was not in vain, while calculating in his mind, wait until the autumn Canton Fair, how to make this area more reasonable arrangements. Such a scene, not only in the industrial automation and intelligent manufacturing exhibition area, but also in the newly established new energy and intelligent network-connected vehicles exhibition area and smart life zone. Thanks to the efforts of Jiang Yiyu and his colleagues, these new zones have become the new highlights of the exhibition. From the news of resuming the offline exhibition at the end of last year to the official launch on April 15 this year, it was difficult enough to organize such a large-scale comprehensive exhibition in just a few months, so why open new exhibition areas? "New products and new technologies bring new vitality to the fair." In the view of Xiao Rong, director of the Canton Fair Work Division of China Foreign Trade Center, the reason why this year's Canton Fair attracted many overseas buyers largely stems from the shining appearance of many new products and technologies. "Today's Made in China is not only synonymous with high cost performance, but also a representative of quality, trend and frontier. By having a new exhibition area, we have a higher order conversion rate and customer stability." Of course, the idea of a new exhibition area was not just proposed this year. "Three or four years ago, we studied the exhibition topics of industrial automation and intelligent manufacturing and began to collect relevant information." Xiao Rong introduced that by visiting enterprises in the field and inquiring and integrating information from materials, China Foreign Trade Center has formed a fairly solid analysis report. "Which provinces are the industrial bases distributed in? What is the main business of the leading enterprises? Where is the space for integration with overseas markets? All these questions can find corresponding answers from our report." Jiang Yiyu said that this has become the basis of the exhibition's efficient and high-quality recruitment. "Focus on the effectiveness is the characteristics of the Canton Fair, we also run the exhibition based on the market demand, and optimize the adjustment at any time." Xiao Rong introduced, from the current attention of buyers and order conversion rate, this Canton Fair has achieved the purpose of consolidating the advantages of traditional comprehensive exhibition and cultivating professional exhibition topics, "enhance the brand, optimize the topics, innovative exhibits, all these have injected new vitality into the Canton Fair." (Reporter Bai Zhiyu Luo Shanshan Li Gang,From People's Daily Online)

On April 1, the 6th China Drug Regulatory Science Conference (2023) was held in Beijing. At the conference, Sun Lei, Director of the Medical Device Technical Review Center of the State Drug Administration, brought a keynote report to introduce the progress of deepening the reform of the medical device review and approval system and the reform results achieved. The text is organized as follows. In the five years since the General Office of the CPC Central Committee and the General Office of the State Council issued the Opinions on Deepening the Reform of the Review and Approval System to Encourage Drug and Medical Device Innovation in October 2017, the Medical Device Technical Review Center of the State Drug Administration (hereinafter referred to as the Device Review Center) has focused on doing the following: Medical device review and approval system reform continues to deepen. 5 years, the ware review center to fully complete the tasks of deepening the review and approval system reform, a scientific and efficient review mechanism has been formed. At the same time, the Center is bold to become a pioneer and practitioner of regulatory science, with "scientific, calm thinking, positive, open attitude" to face the challenges of new technologies, continue to encourage innovation, to create a Chinese modern medical device review system version 1.0. Services to ensure the prevention and control of the epidemic. Since the outbreak of the epidemic, the Center has carried out emergency reviews of epidemic prevention and control products with a high sense of responsibility and mission, and has been the first in the world to issue review points for three categories of new diagnostic products: nucleic acids, antigens and antibodies; it has conducted reviews around the clock to ensure the quality and safety of testing reagents for epidemic prevention and control, as well as therapeutic and monitoring equipment such as ECMO required for critical care and treatment, and market approval; it has tracked the impact of mutated strains on kits in real time. We also track the impact of variant strains on the detection capacity of kits and continuously carry out the assessment of the detection capacity of listed testing reagents to provide a strong guarantee for accurate epidemic prevention and control. Effective operation of quality management system. The Center takes the lead in establishing a technical review quality management system, which extends to cover all personnel and work of the sub-center, strengthening the control of review quality and management of the review process; accelerating the revision of guidelines and review points, building a multi-level guideline system covering high-risk, quantity-concentrated and high-concern professional fields and products, covering 86.9% of the medical device classification catalog, and providing a comprehensive and multi-angle Play the role of product development and technical review of the regulation and guidance. Promote regulatory scientific research. Take the lead in the deep integration of regulatory scientific research and review work, undertake scientific research projects such as the National Key Research and Development Program, take the lead in establishing an artificial intelligence medical device innovation cooperation platform and biomaterials innovation cooperation platform, accelerate the transformation and application of new technologies and new products; take the lead in the field of medical devices to carry out real-world data research, six urgent clinical needs of imported medical device products approved for marketing; high-end medical device equipment Carry out in-depth research and active support, and take the lead in introducing real-world data into IMDRF regulatory documents. Actively participate in international cooperation and exchange. Deeply involved in a number of projects initiated by IMDRF, advocated and chaired the Medical Device Clinical Evaluation (MDCE) Working Group, led the drafting of four outcome documents for global release, and took the lead in achieving a historic breakthrough in China's leadership in the development of international standards for medical device accreditation rules; a number of review-related IMDRF outcome documents were simultaneously transformed into review technical guidelines and specifications. Guidance to promote the construction of sub-centers. The construction of sub-center and the development of the device review center integration planning, the State Drug Administration medical device technical review and inspection of the Yangtze River Delta sub-center, the Bay Area sub-center smoothly set up and run; the first to achieve the unified distribution of the review tasks of the device review center, and the construction of innovative products in the region proactive service mechanism. At the same time also continue to strengthen the culture of the device review center construction. In a series of efforts, the quality and efficiency of the review of the device review center has been effectively improved. 2022, the review completion rate of 99.7% according to the review time frame; product registration review average time of 95 working days, a 2.1% reduction, including medical devices, the average time of the third category of product review reduced to 99 working days. At the same time of rapid development, China's medical device industry is also facing the problem of high-end equipment is "stuck". To this end, the device review center established a review of the front work mechanism, focusing on the potential to achieve key technologies, key materials, core components breakthroughs, with independent intellectual property rights, the possibility of completing domestic substitution to solve the "neck" problem of the product, the establishment of medical device technology review focus to the product development stage forward work mechanism, to promote the development of industrial innovation. Comprehensive help to promote the development of industrial innovation. The Center will take Chinese modern drug regulation as the leader, deepen the reform of the review and approval system, strengthen the review capacity building, help industry innovation and high-quality development, effectively protect the safety of the people with the armament, and start to build a modern review system version 2.0. Source: China Food and Drug Network

Latest News The 133rd Canton Fair is scheduled to return in April 2023. We warmly welcome all international enterprises to exhibit online and offline! Exhibition Time The 133rd Canton Fair is scheduled to open on April 15, 2023. The first period: April 15-19, 2023; The second period: April 23-27, 2023; The third period: May 1-5, 2023; Exchange exhibition period: April 20-22 and April 28-30, 2023. If the exhibition period of offline exhibition is adjusted, it will be announced separately. The online platform will serve for six months (March 16-September 15, 2023). Exhibition topics Phase I: electronics and home appliances, lighting, vehicles and accessories, machinery, hardware and tools, building materials, chemical products, energy; The second period: consumer goods, gifts, home decorations; The third period: textile and clothing, shoes, office luggage and leisure products, medicine and health care, food. Translated with www.DeepL.com/Translator (free version)

According to the "Twelfth Five-Year Plan" for the medical device science and technology industry, the focus will be on supporting 10-15 large medical device enterprise groups, supporting 40-50 innovative high-tech enterprises, establishing 8-10 medical device science and technology industrial bases and 10 national innovative medical device product demonstration application bases, improving the industrial chain, optimizing industrial structure, improve market share, and significantly enhance the international competitiveness of the medical device industry. It is expected that scientific and technological progress and demonstration applications will bring new medical equipment output value of 200 billion yuan, and the proportion of exports to the total international market will increase to more than 5%. The face of China's large medical equipment market is currently monopolized by foreign investors, the leaders said that the medical equipment industry has become a national scientific and technological progress, leading the development of multidisciplinary technology progress engine and an important driving force for economic growth. China's future will vigorously develop domestic medical equipment, reduce medical costs, and through the strict implementation of government procurement law to ensure that financial resources to give priority to the procurement of domestic medical equipment. Informed sources revealed that the Development and Reform Commission, the Ministry of Industry and Information Technology, the Ministry of Finance and the Health Planning Commission are working together to develop "industrial revitalization and technological transformation special", the entire special support funds of 1.5 billion yuan. Among them, the 2013 special development of high-performance medical treatment equipment will focus on medical imaging equipment, in vitro diagnostic products, treatment equipment and other fields, in order to achieve synergistic development of the industry chain upstream and downstream. Among the listed companies of medical equipment, Shenzhen Meirui, China Resources Wandong, Yuyue Medical, Xinhua Medical, Jiangsu Yuyue, Sanno Bio, Kehua Bio and other related companies have good development momentum and deserve attention. At present, the country is implementing the reform of county hospitals around the country, and they are in urgent need of domestic and cost-effective medical devices, and China's medical device industry is ushering in a new round of development opportunities. The recent introduction of favorable national policies for medical devices: The State Food and Drug Administration issued a notice on June 26, 2013, deciding to delegate some of the responsibilities undertaken by the Agency for the approval of changes in the registration certificates of three types of medical devices to provincial food and drug regulatory departments, lowering the threshold for capital entry into the medical device industry and further simplifying the process of government work. The drug regulatory authorities will soon introduce two new medical device regulatory policies, respectively, will guide the registration of innovative medical device products, as well as further simplify the re-registration requirements for medical devices. Industry insiders said that the introduction of the relevant measures will help promote the medical device industry mergers and integration, more conducive to the development of innovative medical device companies. (From China Pharmaceutical Network)

On March 17, 2023, the Center for High Technology Research and Development of the Ministry of Science and Technology (Center for Basic Research Management of the Ministry of Science and Technology) released the top ten advances in Chinese science in 2022, which are: Zhu Rong's roving radar reveals the shallow layered structure of the Martian Utopian Plain; FAST finely carves active repetitive fast radio bursts; a new principle realizes direct electrolysis of seawater to produce hydrogen; reveals the mutational characteristics of new coronavirus and The new principle of switching devices provides new solutions for high-performance mass storage; quantum coherent synthesis of ultracold triatomic molecules; synthesis of ethylene glycol under mild pressure conditions; discovery of new mechanisms for femtosecond laser-induced micro and nano structures of complex systems; experimental confirmation of superconducting state "segmented Fermi surface The "Top Ten Advances in Chinese Science" were awarded to the following The selection activity of "Top Ten Advances in Chinese Science" is led by the Center for High Technology Research and Development of the Ministry of Science and Technology (Center for Basic Research Management of the Ministry of Science and Technology), and has been successfully held for 18 times so far, aiming at promoting the scientific progress of major basic research in China, stimulating the scientific enthusiasm and dedication of the general scientific workers, carrying out basic research It aims to publicize the scientific progress of China's major basic research, stimulate the scientific enthusiasm and dedication of scientific workers, carry out the popularization of basic research, promote public understanding, concern and support for basic research, and create a good scientific atmosphere in society. In 2022, five editorial offices, including Chinese Basic Science, Science and Technology Herald, Proceedings of the Chinese Academy of Sciences, Chinese Science Foundation, and Science Bulletin, recommended more than 600 scientific research advances, all of which were officially published or completed between December 1, 2021 and November 30, 2022. The recommended scientific advances are all research results officially published or completed between December 1, 2021 and November 30, 2022. In December 2022, the Center for High Technology Research and Development of the Ministry of Science and Technology (Center for Basic Research Management of the Ministry of Science and Technology) organized a meeting for the preliminary selection of the Top Ten Scientific Advances in China for 2022. We invited experts to select 30 advances from the recommended advances to enter the final selection. More than 3,000 experts, including academicians of Chinese Academy of Sciences, academicians of Chinese Academy of Engineering, former directors of national key laboratories, former chief scientists of the advisory group and consulting group of the 973 Program, and members of the overall expert group and project leaders of relevant key special projects of the National Key R&D Program, were invited to vote online for the 30 candidate scientific advances, and high-level experts were invited to vote for the top 10 scientific advances. The top 10 scientific advances will be considered and finally selected as the top ten scientific advances in China in 2022.

Currently, countries and regions around the world are paying more and more attention to the development of the medical device industry, and regulation is increasingly strengthened; under the trend of normalizing the prevention and control of the new pneumonia epidemic, the deep integration of digital technology and medical services is driving the medical device industry to upgrade and accelerate the iteration of product innovation; at the same time, with the enhancement of people's health awareness and environmental awareness, the medical device industry is expected to usher in new changes. ...... There are eight major trends in the global medical device industry that deserve attention. 01 Tightening of regulatory environment, enterprises face challenges In 2022, the new EU medical device regulation MDR (EU2017/745) entered its first full-year implementation phase, and the in vitro diagnostic medical device regulation (I VDR) has also been officially implemented since this month. Following the promulgation of the new EU classification criteria for in vitro diagnostic medical devices, more in vitro diagnostic products will be required to pass the mandatory conformity assessment by designated bodies. Although the number of designated certification bodies in this area will increase in the second half of 2022, medical device manufacturers will still face significant challenges from clinical efficacy assessment. In addition, from 1 July 2023, all medical devices planned for the UK market will need to comply with UKCA marking requirements, including those that have already received EU CE marking. 02 Digitalization drives changes in sales and service models Due to the impact of the new crown pneumonia epidemic, the medical device market sales, training and service businesses are accelerating the expansion of online channels, which not only provides more choices and convenience for healthcare providers and clinicians, but also effectively improves the efficiency of medical device manufacturers. Studies have shown that many clinicians and sales representatives prefer virtual interactions, citing their ability to maintain data consistency and improve user satisfaction. It is easy to see that the virtual interaction model will put pressure on medical device manufacturers who have not developed a digital innovation business model to create a customer-centric digital marketing system that meets a range of customer needs for sales, training, service, inventory management, and more. 03 Accelerated innovation in telemedicine diagnostic tools Currently, the level of telemedicine is mainly limited by the lack of remote diagnostic capabilities. Remote diagnosis still has limitations in many areas, such as eye, ear and throat visualization, lung auscultation, temperature measurement, sweating assessment, rash examination, etc. Influenced by the epidemic at home, home medical monitoring technology is expected to see further upgrades, and innovative home testing tools will be widely used to provide more accurate remote diagnosis and treatment services for patients. 04 Digital therapy products are still difficult to be included in medical insurance In recent years, more and more digital therapy (DTx) products have been approved by the FDA and other authorities, and often contain components for treatment, such as asthma and chronic obstructive pulmonary therapy-related products from Propeller Health, and diabetes treatment-related products from Livongo Health. However, very few DTx products are currently covered by health insurance. The reasons for this are, first, that such DTx products are too new to be effectively integrated into the current health care system; second, that new therapies and products do not usually replace existing products, making it difficult to demonstrate sufficient cost-effectiveness to payers; and finally, that it is difficult for payers to pay for the innovative concept of digital tools on a long-term cost-of-care or outcome-based basis. Given these limitations and the lack of a strong evidence-based rationale, DTx products will continue to have a difficult path to inclusion in Medicare. 05 Surgical robotics track competition has never been fiercer As the representative of surgical robots, American Intuitive Surgical's da Vinci surgical robot still holds the majority of the market share at this stage. However, as the patents related to da Vinci surgical robots have been expired since 2016, more and more surgical robots are gradually launched in the field of fierce market competition, and have more advantages in terms of product price, size and haptic feedback. For example, Medtronic's HUGO RAS soft tissue surgical robot has received CE certification from the European Union, Health Canada medical device registration, and an investigational device exemption from the U.S. Food and Drug Administration (FDA) in 2021; in 2021, CMR Surgical, a British surgical robotics company, received $600 In addition, Johnson & Johnson will launch its Ottava surgical robot system in 2020 and plans to conduct clinical trials on it in the second half of 2022. 06 Medical data security will face strict regulation Currently, with the increasing value of medical data, the medical device industry's ability to collect, merge and analyze patient data continues to advance, artificial intelligence technologies including machine learning capabilities are developing rapidly, and digital medical software is gradually becoming an important component of many medical device products. However, due to the highly sensitive nature of medical data and the fact that many medical device manufacturers provide services such as patient data collection, storage and analysis, these services must be fully compliant with data security. Therefore, medical data and technology security is bound to become one of the regulatory priorities of the relevant departments. For example, the FDA has established the Digital Health Center of Excellence (DHCE) and launched a digital health software pre-certification program to enhance the regulation of related innovative technologies. 07 Real World Evidence Acceptance and Utilization Increases Currently, real-world evidence (RWE), which is of high quality, reliability and relevance, is gradually being widely adopted by regulatory agencies worldwide, such as in medical device clinical trial studies for product safety and efficacy monitoring, to support relevant regulatory decisions. In addition, regulatory agencies are actively using RWE to focus on innovative study designs for medical device specific trial methods to address relevant regulatory research questions. Meanwhile, more and more medical device manufacturers are studying how to better use RWE to develop product study plans to optimize trial design, patient enrollment, and other elements to ensure product safety and clinical efficacy. 08 Medical waste disposal needs to be upgraded Currently, the medical device industry produces and uses a large number of disposable plastic packaging materials and products, and although they have many advantages such as sterility, low cost, and ease of manufacture, they also generate a large amount of medical waste. In the past, discussions about medical waste usually centered on its potential risk of disease transmission; nowadays, the environmental pollution caused by large amounts of plastic waste products (such as infusion bags) is attracting increasing attention and focus from society. Although the medical device industry has made some progress in improving product recyclability, progress in this area is still insufficient as resource utilization is still low and many recyclables often end up as waste products. Therefore, relevant companies can consider using biodegradable materials in the production process, thus reducing the generation of package waste; in addition, they can also innovate on material sterilization technology to improve package reusability.

Currently, countries and regions around the world are paying more and more attention to the development of the medical device industry, and regulation is increasingly strengthened; under the trend of normalizing the prevention and control of the new pneumonia epidemic, the deep integration of digital technology and medical services is driving the medical device industry to upgrade and accelerate the iteration of product innovation; at the same time, with the enhancement of people's health awareness and environmental awareness, the medical device industry is expected to usher in new changes. ...... There are eight major trends in the global medical device industry that deserve attention. The regulatory environment is tightening and companies are facing challenges In 2022, the new EU medical device regulation MDR (EU2017/745) entered its first full-year implementation phase, and the in vitro diagnostic medical device regulation (IVDR) has also been officially implemented since this month. Following the promulgation of the new EU in vitro diagnostic medical device classification standards, more in vitro diagnostic products will be required to pass the mandatory conformity assessment by designated bodies. Although the number of designated certification bodies in this area will increase in the second half of 2022, medical device manufacturers will still face significant challenges from clinical efficacy assessment. In addition, from 1 July 2023, medical devices planned for the UK market will need to comply with UKCA marking requirements, including those that have already received EU CE marking. Digitalization drives changes in sales and service models Due to the impact of the new crown pneumonia epidemic, the medical device market sales, training and service businesses are accelerating their expansion into online channels, which not only provides more options and convenience for healthcare providers and clinicians, but also effectively improves the efficiency of medical device manufacturers. Studies have shown that many clinicians and sales representatives prefer virtual interactions, citing their ability to maintain data consistency and improve user satisfaction. It is easy to see that the virtual interaction model will put pressure on medical device manufacturers who have not developed a digital innovation business model to create a customer-centric digital marketing system that meets a range of customer needs for sales, training, service, inventory management, and more. Accelerated innovation in telemedicine diagnostic tools Currently, the level of telemedicine is mainly limited by the lack of remote diagnostic capabilities. Tele-diagnosis still has limitations in many areas, such as eye, ear and throat visualization, lung auscultation, temperature measurement, sweating assessment, rash examination, etc. Influenced by the epidemic at home, home medical monitoring technology is expected to see further upgrades, and innovative home testing tools will be widely used to provide more accurate remote diagnosis and treatment services to patients. Digital therapy products are still difficult to incorporate into medical insurance In recent years, more and more digital therapy (DTx) products have been approved by authorities such as the FDA, and often contain components related to treatment, such as products related to asthma and chronic obstructive pulmonary treatment from Propeller Health, and products related to diabetes treatment from Livongo Health. However, very few DTx products are currently covered by health insurance. The reasons for this are, first, that such DTx products are too new to be effectively integrated into the current health care system; second, that new therapies and products do not usually replace existing products, making it difficult to demonstrate sufficient cost-effectiveness to payers; and finally, that it is difficult for payers to pay for the innovative concept of digital tools on a long-term cost-of-care or outcome-based basis. Given these limitations and the lack of a strong evidence-based rationale, DTx products will continue to have a difficult path to inclusion in Medicare. Surgical robotics track is more competitive than ever As a representative of surgical robots, the da Vinci surgical robot from Intuitive Surgical still holds the majority of the market share at this stage. However, as the patents related to da Vinci surgical robots have been expired since 2016, more and more surgical robots are gradually launched in the field of fierce market competition, and have more advantages in terms of product price, size and haptic feedback. For example, Medtronic's HUGO RAS soft tissue surgical robot has received CE certification from the European Union, Health Canada medical device registration, and an investigational device exemption from the U.S. Food and Drug Administration (FDA) in 2021; in 2021, the British surgical robotics company CMR Surgical received $600 In addition, Johnson & Johnson will launch its Ottava surgical robot system in 2020 and plans to conduct clinical trials on it in the second half of 2022. Medical data security will face strict regulation Currently, with the increasing value of medical data, the medical device industry's ability to collect, merge and analyze patient data continues to advance, artificial intelligence technologies, including machine learning capabilities, are developing rapidly, and digital medical software is becoming an important component of many medical device products. However, due to the highly sensitive nature of medical data and the fact that many medical device manufacturers provide services such as patient data collection, storage and analysis, these services must be fully compliant with data security. Therefore, medical data and technology security is bound to become one of the regulatory priorities of the relevant departments. For example, the FDA has established the Digital Health Center of Excellence (DHCE) and launched a digital health software pre-certification program to enhance the regulation of related innovative technologies. Increased acceptance and utilization of real-world evidence Currently, real-world evidence (RWE), which is of high quality, reliability and relevance, is being widely adopted by regulatory agencies worldwide, such as in medical device clinical trial studies for product safety and efficacy monitoring, to support relevant regulatory decisions. In addition, regulatory agencies are actively using RWE to focus on innovative study designs for medical device specific trial methods to address relevant regulatory research questions. At the same time, more and more medical device manufacturers are studying how to better use RWE to develop product study plans to optimize trial design, patient enrollment, and other elements to ensure product safety and clinical efficacy. Medical waste disposal needs to be upgraded Currently, the medical device industry produces and uses a large number of disposable plastic packaging materials and products, and although they have many advantages such as sterility, low cost, and ease of manufacture, they also generate a large amount of medical waste. In the past, discussions about medical waste usually centered on its potential risk of disease transmission; nowadays, the environmental pollution caused by large amounts of plastic waste products (such as infusion bags) is attracting increasing attention and focus from society. Although the medical device industry has made some progress in improving product recyclability, progress in this area is still insufficient as resource utilization is still low and many recyclables often end up as waste products. Therefore, relevant companies can consider using biodegradable materials in the production process, thus reducing the generation of package waste; in addition, they can also innovate on material sterilization technology to improve package reusability.

Since 2022, the State Drug Administration adhere to the Xi Jinping thought of socialism with Chinese characteristics in the new era as a guide, a deep understanding of the implementation of the fundamental value of "adhere to the people first", the strict implementation of the "most rigorous standards" requirements, to promote high-quality development as the theme, the overall promotion of medical device standards work. The theme, the overall promotion of medical device standards work. A. Strengthen the standard organization system construction (a) actively promote the urgent need for regulation and innovation in the field of setting up new standardization organizations. 2022 the first joint application with other industry authorities of the national medical equipment industry and the application of standardization working group was formally approved for establishment, the standardization of Chinese medicine equipment technical focal point was formally approved for establishment. National medical protective equipment standardization working group and medical device reliability and maintainability, oral digital medical device standardization technology focal point unit was approved for preparation, is actively formed according to the procedure. Further fill the blank areas of medical device standardization organization, optimize the structure and layout of the standard organization system. As of December 31, 2022, medical device standards and technical organizations have reached 37, including 13 general standardization committee (TC), 13 substandardization committee (SC), a standard working group and 10 technical focal points. (B) to strengthen the management of the technical focal point unit. In order to further standardize the formation of medical device standardization technical focal point unit, replacement, adjustment and supervision and management, scientific medical device standardization work, the organization developed and issued the "medical device standardization technical focal point unit management rules (for trial implementation)", to strengthen the technical focal point unit management. (C) improve the assessment mechanism of the standardization committee. Based on the assessment and evaluation work in previous years, summarize the experience of the organization to revise and improve the "Medical Device Standardization Technical Committee assessment and evaluation rules", the deployment of the organization to carry out the assessment and evaluation of the Medical Device Standardization Technical Committee in 2022, to further optimize and improve the Medical Device Standardization Committee and the assessment and evaluation index system of the unit, and improve the assessment and incentive mechanism. Second, optimize the assessment of mandatory standards According to the "Medical Device Mandatory Standards Optimization Work Program" requirements, the organization completed 396 medical device mandatory standards and 62 mandatory standards in research project optimization assessment. Optimization assessment results: 458 medical device mandatory standards and research projects, recommended to recommend 125, 23 repealed, 136 revised, 174 continue to be effective Actively promote the implementation of the results of the optimization assessment of mandatory medical device standards, in September 2022, the "State Drug Administration on the repeal of YY 1075-2007 "rigid uterine endoscope" and other 20 mandatory industry standards for medical devices announcement" (No. 75 of 2022) "State Drug Administration on the conversion of 92 mandatory industry standards for medical devices and projects under research into recommended industry standards and projects under research Project Announcement" (No. 76 of 2022) was officially issued, while actively reporting mandatory national standards and projects under study to optimize the assessment recommendations, and guide the revision project to complete the revision work as planned to achieve a comprehensive optimization of the mandatory medical device standards system to improve quality. Third, optimize the technical system of medical device standards In 2022, 42 national standards for medical devices were issued, and 117 medical device industry standard revision projects (including 23 mandatory projects and 94 recommended projects); 40 national standards for medical devices were issued, 114 medical device industry standards, and 4 medical device industry standard revision sheets. As of December 31, 2022, a total of 1919 medical device standards (see Table 1), the medical device standard technical system continues to optimize. 3.png (A) increase the development of medical device standards for emerging industries 2022 focus on supporting 64 artificial intelligence medical devices, new biomedical materials, accompanying diagnostics, new molecular diagnostic technology and other high-end, innovative areas of medical device industry standards development. To collagen and other innovative biomedical materials in China's advantage in the field of standards focus on support, to take rapid procedures, the organization of "recombinant humanized collagen" regulatory urgent standard establishment, rapid development, priority review, and synchronize the organization to promote international standards pre-research and new project applications, to seize the opportunity to international standards. (II) The number of standards continues to improve As of December 31, 2022, a total of 1919 medical device standards, the number of medical device standards has steadily increased in recent years. (III) The system structure is more optimized As of December 31, 2022, according to the standard specification object statistics, the current effective medical device standards in the basic standard 326, accounting for 17%; management standards 49, accounting for 3%; method standards 461, accounting for 24%; product standards 1083, accounting for 56%, the number of basic standards increased year by year (see Figure 4). Of the 154 standards released in 2022, 42 basic standards, accounting for 27%; 6 management standards, accounting for 4%; 30 method standards, accounting for 20%; 76 product standards, accounting for 49% (see Figure 5), the structure of the medical device standard system is further optimized. (D) more comprehensive coverage of the field As of December 31, 2022, according to the standard specification object statistics, the current valid medical device standards in accordance with the Chinese Standard Classification of Literature, mainly categorized in medical devices (C30) to medical hygiene supplies (C48), accounting for the top 5 are: medical laboratory equipment (C44) 14%, orthopedic surgery, orthopedic instruments (C35) 11%, general and microsurgery Instruments (C31) 11%, medical devices comprehensive (C30) 10%, dentistry instruments, equipment and materials (C33) 9% (see Figure 6). Medical device standards comprehensively cover all technical fields of medical devices such as medical electrical equipment, surgical instruments and surgical implants. Fourth, standardize management to improve the system mechanism Implementation of the "State Drug Administration State Standardization Administration Committee on the further promotion of medical device standardization work of high-quality development of the views", to further improve the management of medical device standards, from the medical device standards to improve the management system in all aspects of the revision, to explore the mechanism of innovation. First, to explore the establishment of encouraging enterprises to participate in the standardization mechanism. In accordance with the principle of "while carrying out pilot, while establishing the system", the pilot open call to the community for the first draft of six medical device standards, the organization drafted the "business-led drafting of recommended industry standards for medical devices (for trial)", to explore new mechanisms for business-led drafting of recommended industry standards to promote the supply of medical device standards More high-quality, timely and diversified. Second, to enhance the standard management level. Organization to carry out "medical device mandatory standards to determine the principles of" "medical device national standards and industry standards to determine the principles of" the development of a coordinated guide to the standard hierarchy and standard categories of scientific and accurate division, to do a good job of national standards, industry standards, two levels and mandatory standards, recommended standards two categories of standard management, medical device standards "a chess game ". Third, strengthen the refinement of the key aspects of the standard management. Revise the "medical device standard validation work rules" to strengthen the standard validation; issued the "medical device standard feedback and processing mechanism", continue to optimize the medical device standard information feedback and communication channels, and further improve the standard implementation feedback mechanism. V. Facilitate the implementation of the new GB 9706 series standards In order to cooperate with GB 9706.1-2020 "medical electrical equipment Part 1: General requirements for basic safety and basic performance" the smooth implementation of the GB 9706 series of standards to promote the revision of the work. Organization to develop standard implementation rules, the preparation and publication of standard interpretation and test procedures, the organization compiled "GB 9706.1 old and new standard comparison table" "GB 9706.1-2020 test and test equipment reference list". The organization recorded 59 published standard interpretation video, the new GB 9706 series standard cloud classroom opened on the website of the device standard management center, free to the whole society, more than 1.4 million people online browsing and learning; organization of 2 weeks of the new GB 9706 series standard online public welfare training, more than 46,000 units from 31 provinces (autonomous regions, municipalities directly under the Central Government) and Xinjiang Production and Construction Corps More than 46,000 units from 31 provinces (autonomous regions, municipalities directly under the Central Government) and Xinjiang Production and Construction Corps and more than 206,000 people attended the training, to achieve the training content and training scope of the two "full coverage", further unifying the understanding of the new GB 9706 series of standards, to promote the smooth implementation of the new GB 9706 series of standards has laid a solid foundation. Sixth, strengthen the implementation of standards First, the organization carried out the evaluation of the implementation of medical device standards in 2022. Organization issued a work notice, the development of the implementation of the evaluation work plan, a clear assessment of the scope and work requirements, the organization of the medical device standardization committee, the technical focal point unit selected applicable standards, from the technical content of the standard, including the applicability of the standard, the reasonableness of key technical requirements, the feasibility of test methods, the accuracy of the scope of application, and the level of comparison of international standards, as well as the standard dissemination, promotion, implementation, application In order to further improve the quality of standards and promote the effective implementation of standards, we will carry out assessments in the areas of promotion, implementation and feedback, and strive to objectively and fairly reflect the implementation and effectiveness of the relevant standards. Second, to further improve the implementation of medical device standards assessment mechanism. In summing up the implementation of medical device standards evaluation of the pilot, promotion of work based on experience, the organization to develop "medical device standards implementation evaluation work rules" to form a closed-loop management of the entire process of medical device standards. Third, strengthen the dissemination of standards. Organization to develop and publish the 2022 medical device standards dissemination training program on the website of the Device Standard Management Center, organize online training courses on comprehensive knowledge of medical device standards, and strengthen the standardization regulations and policies training for the standardization committees, technical subordination unit chairman (leader), deputy chairman (deputy leader), the Secretary-General and relevant staff of the Secretariat. The organization of the standardization committees, technical units held a total of 27 standards dissemination training, 174 newly released in recent years, the basis of the general, extensive national and industry standards for medical devices to carry out dissemination training, unified understanding of the standard, to help the implementation of the standard. Seven, enhance the level of international standardization work (A) China's leading development of three international standards officially released March 8, 2022, by the National Medical Infusion Apparatus Standardization Technical Committee (SAC/TC106) led the development of the international standard ISO 8536-15 "medical infusion set Part 15: single-use light-absorbing infusion set" has been officially released. This international standard was developed over a period of 4 years with the participation of many countries such as Germany and the United States, forming a globally unified technical index and testing test method for light-absorbing infusion sets, filling the gap of international standards. On April 19, 2022, the international standard document ISO/TS 5798:2022 "Requirements and Recommendations for the Detection of Novel Coronavirus (SARS-CoV-2) by Nucleic Acid Amplification Method in In Vitro Diagnostic Test Systems", which was initiated by China, was officially released, contributing Chinese wisdom to the international standardization of epidemic prevention and control and promoting global epidemic prevention and control. It has played a positive role in promoting global epidemic prevention and control. In July 2022, ISO/TS 24560-1:2022 "Clinical dGEMRIC and T2-mapping Magnetic Resonance Imaging Evaluation of Regenerative Articular Cartilage for Tissue-Engineered Medical Products", which was developed by the National Technical Committee for Standardization of Surgical Implants and Orthopaedic Devices (SAC/TC110/SC3), was officially released. (2) Actively promote foreign advanced standards (B) actively promote the advanced foreign standard making and revision On July 1, 2022, the Institute of Electrical and Electronics Engineers (IEEE) standard project IEEE P2801 "Quality Management of Medical Artificial Intelligence Datasets", a foreign advanced standard led by the standardization technical focal point of artificial intelligence medical devices, was officially released and implemented. The standard has gained wide attention from the international community during the drafting stage and has been cited in the AI policy documents of many countries (regions). 21 September 2022, the standard project IEEE P3191 "Recommended Standard for Clinical Performance Monitoring of Machine Learning Medical Devices", led by the standardization technology focal point unit for AI medical devices, was formally approved and established, contributing to the healthy development of the global AI medical device industry. (2) Contribute to the healthy development of the global artificial intelligence medical device industry. (iii) Active participation in international standardization activities The organization participated in the International Organization for Standardization (ISO) standard making and revision work meetings for a total of 50 times, represented our country to participate in various international standards of counterpart ISO voting 176 times, the new ISO registered experts 10 people, actively participate in international standardization activities. (D) continue to enhance the degree of consistency with international standards To establish a standard update mechanism with international standards, comprehensively sort out the conversion of existing international standards for medical devices, and clarify the time schedule for the conversion of international standards that should be converted. 117 applications for conversion of international standards for medical devices will be submitted in 2022, twice as many as in 2020, so as to continuously improve the consistency with international standards. degree. Eight, enhance the level of standard services In order to play the role of technical support of standards, in 2022, the organization compiled and made public the "Compilation of Medical Device Standards Catalogue (2022 Edition)" and "China Medical Device Standards Catalogue and Scope of Application", the scope of application of the current valid medical device standards and information on the standard level, effectiveness, name, focal point, etc., according to the medical device technology field combing public. In 2022, 279 medical device standards establishment information, 175 draft standards and preparation instructions, 57 standards publicity, members of the call for information related to 57, the existing 237 medical device mandatory industry standard text and 1,000 non-targeted recommended industry standard text have been All public.