NMPA Announces 2026 Plan to Revise 82 Medical Device Standards; Prominent IVD Coagulation Firm Secures Government Equity Investment

1. The General Office of the National Medical Products Administration Announced the 2026 Plan for the Development and Revision of Medical Device Industry Standards

Recently, in accordance with the requirements of the Measures for the Administration of Medical Device Standards and the Specifications for the Management of Medical Device Standard Formulation and Revision, the National Medical Products Administration organized the selection of projects for the formulation and revision of medical device industry standards for 2026. After soliciting public opinions and expert consultations, 80 projects for the formulation and revision of medical device industry standards for 2026 and two projects for the development of foreign language versions of medical device industry standards were determined and are now being announced. The announcement includes the 2026 Plan for Mandatory Medical Device Industry Standards Formulation and Revision Projects, the 2026 Plan for Recommended Medical Device Industry Standards Formulation and Revision Projects, and the 2026 Plan for Foreign Language Version Development Projects of Medical Device Industry Standards. Please visit the official website of the National Medical Products Administration for more information. (China Food and Drug Administration Network)

2. Sunnyou Establishes China's Provincial Brain-Computer Interface Rehabilitation Equipment Technology Innovation Center

Recently, according to People's Finance and Economics News, the Henan Provincial Department of Science and Technology announced the approval for the construction of the Henan Province Technical Innovation Center. Among them, the "Henan Brain-Computer Interface Rehabilitation Equipment Technology Innovation Center," led by Sunnyou Medical, has been approved as China’s first provincial-level brain-computer interface technology innovation platform. This center, led by Sunnyou Medical in collaboration with Zhengzhou University and the First Affiliated Hospital of Zhengzhou University, will accurately address clinical needs, tackle key core technologies, and promote technological innovation and breakthroughs in the field of brain-computer interface rehabilitation equipment through multi-party cooperation and resource integration. This effort will inject strong momentum into the thriving development of this industry and help China make greater progress in related medical technology fields. (Hexun.com)

3. During the "15th Five-Year Plan" period, Beijing will promote the extension of social emergency AED deployment to communities.

Recently, a press conference was held to interpret the "Beijing '15th Five-Year Plan' Outline." During the '14th Five-Year Plan' period, Beijing residents' health levels significantly improved, with life expectancy increasing to 83.93 years, and infant and maternal mortality rates declining. Medical resources continued to grow, and medical standards remained leading. In the '15th Five-Year Plan' period, Beijing will promote the health-first development strategy, improve the medical and health service network, optimize the functional positioning of medical institutions, implement foundational projects, improve the tiered diagnosis and treatment system with a focus on grassroots healthcare, promote the balanced distribution of medical resources, enhance social emergency response capabilities, and extend AED deployment to communities. It will also improve the pharmaceutical and healthcare system mechanisms, deepen public hospital reforms, and promote the construction of research-oriented hospitals. Additionally, it will strengthen the population development support and service system, advocate for positive views on marriage and childbirth, and enhance women's and children's health services. (Sina.com)

4. IVD Listed Company Secures $600 Million Order

Recently, CowealthGroup announced that the company, together with Nanjing BenQ Medical Center and Suzhou BenQ Hospital, has jointly signed the "Long-term Procurement Agreement." The agreement stipulates that BenQ Hospitals will purchase in vitro diagnostic reagents and consumables from the company, which will also provide corresponding comprehensive services. The total procurement amount by BenQ Hospitals over 96 months shall be no less than RMB 6.00 billion. The 96-month period starts on January 23, 2026, or when the total procurement amount reaches RMB 7.20 billion, whichever comes first. If the total procurement amount by BenQ Hospitals does not reach RMB 6.00 billion within 96 months, they should make up the total procurement amount to RMB 6.00 billion within 15 days after the end of the procurement period and pay off the goods value within 120 days after making up the order. If BenQ Hospitals have fully purchased the reagents and consumables listed in the contract appendix as agreed but fail to reach the minimum procurement amount due to reasons not attributable to BenQ Hospitals, both parties should negotiate a solution amicably. The total procurement amount is calculated by combining the procurement amounts of Nanjing BenQ Medical Center and Suzhou BenQ Hospital. (IVD Information)

5. Medtronic Collaborates with Mindray

Recently, Medtronic and Mindray announced the expansion of their collaboration in patient monitoring technology from hospitals to outpatient surgery centers in the U.S., simplifying access and integration of advanced monitoring solutions, reducing costs, improving clinical outcomes, and enhancing patient care. The rising demand for outpatient surgeries provides an opportunity for Mindray to expand in the U.S. market. Wayne Quinn, President of Mindray North America, stated that the expanded partnership reflects a shared vision of making advanced monitoring technologies more widely accessible. Blake Tatum, Vice President of U.S. Commercial Operations for Medtronic's Acute Care and Monitoring division, noted that integrating multiple leading Medtronic technologies into Mindray’s innovative platform makes advanced monitoring more accessible in outpatient surgery centers. The two companies have a long history of collaboration in acute care, with Mindray North America actively incorporating next-generation Medtronic monitoring technologies. Additionally, both companies will leverage an integrated distributor network to offer a more efficient and cost-effective procurement process. (Medical Device Business Review)

6. Portable Neonatal Incubator Approved by FDA

Recently, the core product of the British company mOm Incubators, the Essential Incubator, received FDA 510(k) marketing clearance, becoming one of the few portable neonatal incubator systems recognized in the United States. It can now officially enter the U.S. market to provide continuous and stable temperature management for premature infants. This device is positioned as a mobile temperature control system designed for non-NICU scenarios such as delivery rooms, grassroots hospitals, transport care, rural and remote areas, and humanitarian relief, emphasizing continuous use from childbirth to postpartum care. Its core innovation lies in systematically reconstructing the neonatal care process, reflected in aspects like lightweight and mobile design, continuous constant temperature and multi-power support, open structure and ease of use, compliance with safety standards, and compatibility with various care models. The device has already obtained both CE certification and FDA 510(k) approval successively. (Siyu MedTech)

7. R&D Design Services Accelerate the Clinical Transformation of Medical Research Achievements

The R&D of medical devices is a complex and rigorous process, involving multiple aspects such as technology, regulations, and clinical practices. Orschda has a 20,000-square-meter science and innovation center and has established a Medical Device Research Institute dedicated to the clinical transformation of medical research achievements. It boasts a high-level, international, multidisciplinary professional team proficient in the entire process of R&D, regulations, clinical trials, registration, and production, capable of developing and producing various complex and innovative products. With extensive project experience and industry resources, it has built a standardized, regulated, and digitalized full-process service system. It provides one-stop services from preliminary market research, product concept generation, product design and development to prototype production and testing. To date, Orschda has had over 200 projects enter the review stage, more than 100 projects under development, with a 100% success rate in transformation. (Orschda compilation)

8. Well-known IVD Coagulation Company Receives Fiscal Equity Investment

Recently, Shandong Aikoda Biotechnology Co., Ltd. received tens of millions of yuan in equity investment from the provincial financial authorities of Shandong. This round of investment was carried out by Shandong Caijin Group. Aikoda focuses on technological innovation and independent research in the field of coagulation diagnostics, adhering to the development principle of "technological self-reliance and industrial contribution to the country." It has achieved a full-chain layout in key raw materials, instruments, reagents, and technical services, gradually growing into one of the few technology companies in the coagulation testing sector with complete industrial capabilities and leading competitiveness. The fiscal equity investment funds obtained this time will be mainly used for the following key areas: increasing R&D investment, accelerating key technology breakthroughs and iterations, consolidating and expanding the technological leadership advantage; expanding production scale, introducing advanced manufacturing systems, improving product quality and delivery capabilities; deepening domestic market layout, actively exploring international opportunities, enhancing brand core competitiveness; attracting more industry talents, and building a more innovative and competitive professional team. (IVD Tool Person)