Weekly Medical Device News Roundup [Dec 22–28]: M&A, Funding, Regulatory Approvals, and Global Expansion

Recently, BOE Technology Group and Shenzhen Mindray Bio-Medical Electronics Co., Ltd. held a strategic cooperation signing ceremony in Shenzhen. Both parties will leverage their respective strengths in display technology and medical devices to carry out in-depth cooperation in multiple fields such as display devices, smart hospitals, and in vitro diagnostics, promoting the technological innovation and industrial implementation of "IoT + Smart Healthcare." At the signing ceremony, cooperative products including portable ultrasound equipment, a 24-inch high-end VMAX display terminal for monitoring, and DR flat panel detectors were officially unveiled. Meanwhile, the two parties hosted the "BOE Tech Day at Mindray" event to showcase innovative achievements from their collaboration. BOE and Mindray Medical have a long-standing cooperation that has been continuously expanding in scale since 2016, and they will jointly explore an innovative model for "IoT + Smart Healthcare" in the future.

Recently, Affluent Medical announced acquisition agreements with Caranx Medical and Artedrone for a total of approximately $32.9 million. Through strategic integration, the new enterprise, Carvolix, will be established. The new company will incorporate AI-driven autonomous micro-robotics technology, aiming to make complex life-saving surgeries more accessible, creating autonomous and efficient cardiac catheterization labs to benefit patients worldwide. Truffle Capital aims to unlock the potential of the three companies through this integration, building an enterprise that serves 21st-century interventional cardiologists. Carvolix will focus on breakthroughs in heart valve replacement and stroke treatment, addressing significant unmet medical needs in a vast market. Currently, only 17% of patients suitable for transcatheter aortic valve implantation (TAVI) actually undergo the procedure, and merely 5% of ischemic stroke patients receive mechanical thrombectomy, indicating enormous market potential.

Recently, Shenzhen Raylio Group officially signed a contract with the Medical Laboratory Center of Luohu Hospital Group to jointly establish an "IVD Core Raw Material Pilot Base." Relying on a government-approved public service platform, the base focuses on key aspects such as IVD reagent and instrument performance evaluation and clinical evaluation, providing end-to-end services. The collaboration has received significant attention and on-site witnessing from relevant departments at both the city and district levels of Shenzhen, marking a substantial step forward in promoting the domestic production of IVD core raw materials and deepening the innovative path of "medical-engineering integration" in Shenzhen. The Medical Laboratory Center of Luohu Hospital Group integrates clinical testing, research, teaching, and translational application, while Shenzhen Raylio Group is a leading comprehensive raw material supplier in China’s IVD industry. The jointly built base will fully leverage the strengths of both parties, focusing on overcoming challenges in clinical evaluation and pre-experimental stage evaluations for IVD products, achieving close integration of industry, academia, research, and medicine.

Recently, Roche Diagnostics China and Ruijin Hainan Hospital have collaborated to establish the "Pilot Demonstration Center for Special Access Products." This collaboration marks a new phase of deep integration between multinational healthcare enterprises and national research hospitals under the policy framework of the Hainan Free Trade Port. Ruijin Hainan Hospital leverages its policy advantages to play a core role in policy implementation and clinical transformation. This partnership has created a collaborative model focused on innovative practices for special access products, establishing an end-to-end collaboration system to accelerate innovative applications, deepen scientific research transformation, and build a talent hub. Since 2021, Roche Diagnostics has partnered with the Boao Hainan government, becoming an in vitro diagnostics company utilizing the innovative pathways of the Free Trade Port to expedite import registration. So far, 16 groundbreaking solutions have been introduced as specially approved imported medical devices urgently needed for clinical use at Ruijin Hainan Hospital.

Five New Subsidiaries of MicroPort® and Its Affiliates Receive "National High-Tech Enterprise" Designation, Bringing the Total Number of Subsidiaries with This Recognition to 26, Demonstrating Their Achievements in Innovation R&D and Technology Transfer. The Five New Subsidiaries Cover Cutting-Edge Fields Such as Surgical Robotics, Precision Medicine, and High-End Devices: Shanghai MicroPort Medical Robot offers comprehensive robotic intelligent surgery solutions, with products approved for use in multiple countries; Suzhou MicroPort MedBot develops innovative intelligent treatment solutions, with products installed in multiple countries; MicroPort UroCare focuses on high-end non-vascular interventional devices; Shentu Medical researches implantable and interventional medical devices for central nervous system diseases; Shanghai Zoxel Medical’s core products have significant clinical advantages and have been commercialized in China and Europe. This recognition affirms the enterprises' scientific research systems and technology transfer capabilities and reflects the increasing maturity of MicroPort®’s full-chain system. MicroPort® will continue to bring new momentum to the industry.

Recently, the Hainan Provincial Drug Administration held a seminar at Hainan Medical University and jointly signed a strategic cooperation framework agreement. The two parties engaged in in-depth discussions on exploring a new model of integrating "government, university, industry, research, and application," strengthening the scientific research and talent cultivation for drug regulation, and jointly serving the high-quality development of Hainan's biopharmaceutical industry. This collaboration holds significant importance for promoting the "four-medical linkage" of medical education, healthcare, pharmaceuticals, and medical insurance. It will also further boost the development of Hainan’s biopharmaceutical industry. With the continuous advancement of the Hainan Free Trade Port, it is imperative to develop the biopharmaceutical industry and cultivate regulatory talent for drugs and medical devices. Strengthening collaboration in areas such as pharmaceutical park construction, regulatory talent training, and research cooperation will collectively enhance the quality and growth of Hainan’s biopharmaceutical industry, fostering its prosperity within the Hainan Free Trade Port.

Recently, the National Medical Products Administration (NMPA) released the "Regulations on the Administration of Medical Device Export Sales Certificates." The Regulations will come into effect on May 1, 2026. The Regulations are an important measure by the NMPA to implement the "Opinions of the General Office of the State Council on Comprehensively Deepening the Reform of Drug and Medical Device Supervision to Promote High-Quality Development of the Pharmaceutical Industry" (Guo Ban Fa [2024] No. 53), strongly supporting medical device exports and optimizing the handling of service-related matters for issuing medical device export sales certificates by drug regulatory authorities. The issuance of the Regulations will provide broader support and more convenient services for the export of China's medical device products, help accelerate the "going global" of China's medical device products, better reach the world, and contribute to global public health.

Recently, the National Medical Products Administration (NMPA) issued the "Regulation on Filing and Administration of Internet Drug and Medical Device Information Services." The Regulation is an important measure by the NMPA to implement the State Council's spirit of deepening the reform of separating licenses and permits. Providers of internet drug and medical device information services must file for registration with the provincial drug regulatory authorities in their locality according to the requirements of the Regulation. The Regulation specifies relevant matters such as the content, conditions, procedures, and required materials for filing internet drug and medical device information services. The issuance of the Regulation will further standardize the administration of filing for internet drug and medical device information services and effectively guide local regions in carrying out filing work in a standardized manner.

Recently, the Inner Mongolia Autonomous Region Drug Administration issued four regulatory administrative discretion benchmarks for "two products and one device," including administrative licensing, administrative inspection, administrative enforcement, and administrative rewards, which will be implemented starting January 1, 2026. Among these, the administrative licensing benchmark covers 26 main categories and 66 sub-items, specifying various standards; the administrative inspection benchmark’s general provisions clarify objectives, scope of application, etc., while the specific provisions cover 15 inspection items, stipulating detailed content; the administrative enforcement benchmark provides specific discretion regulations for 12 enforcement measures, detailing implementation, extension, termination scenarios, prohibited scenarios, and setting conditions under which enforcement is not applicable; the administrative rewards benchmark specifies 10 items, providing operational standards. The Autonomous Region Drug Administration also requires each league and city market supervision bureau to refer to the administrative licensing benchmark to formulate applicable benchmarks for their respective regions.

Recently, the Science and Technology Department of the Ministry of Industry and Information Technology and the Medical Device Registration Management Department of the National Medical Products Administration announced the shortlisted list for the 2025 AI Medical Device Innovation Task under the "Open Competition for Leadership" initiative. A total of 182 projects nationwide were selected, with 41 projects from Beijing making the cut, including five brain-machine hybrid intelligence products. This highlights the technological leadership and industrial cluster advantages of Changping Future Science City in Beijing in the field of brain-computer interface medical devices. The competition focuses on three key areas: intelligent assisted diagnosis, brain-machine hybrid intelligence, and supporting environments, selecting organizations to tackle challenges to achieve independent control and clinical transformation breakthroughs in high-end intelligent medical devices. After completing their tasks, the winning units will receive policy support in financing, evaluation, registration, and hospital adoption, accelerating the clinical application and industrialization of AI medical device products in Beijing and reinforcing the capital’s core position in medical science and technology innovation.

Recently, according to Changsha fiscal news, the Ministry of Finance and the Ministry of Industry and Information Technology jointly issued an opinion to implement the State Council General Office's "Notice on Implementing Domestic Product Standards and Related Policies in Government Procurement." The opinion requires the implementation of domestic product standards and related policies in government procurement to build a unified, open, and competitively orderly market system, ensuring enforcement starting January 1, 2026. The opinion emphasizes that implementing domestic product standards is a system innovation aimed at optimizing the business environment, granting national treatment to foreign-funded enterprises, and supporting dual circulation development domestically and internationally. Domestic products must be produced within China, including items produced in bonded areas and other special customs supervision zones; medical devices must obtain registration certificates from drug regulatory authorities. The Ministry of Finance, together with the Ministry of Industry and Information Technology and others, will formulate component cost ratio requirements by product and set a transition period. Purchasers must review the accuracy of the "Declaration Letter" submitted by suppliers; if counterfeit behavior is discovered, the finance department will handle it seriously. At the same time, the requirement to treat domestic and foreign enterprises equally must be strictly enforced, prohibiting any discriminatory treatment.

Recently, the Hainan Provincial Drug Administration released the "Several Measures to Support the Agglomeration and Development of Pharmaceutical, Medical Device, and Cosmetic Industries in Haikou National High-Tech Industrial Development Zone." The aim is to thoroughly implement the overall plan for the construction of the Hainan Free Trade Port, accelerate the development of the biopharmaceutical industry, and fully leverage the role of Haikou National High-Tech Industrial Development Zone as the main base for pharmaceutical industry clusters in Hainan Province. Specific measures include: supporting the construction of high-level public technology service platforms; enhancing the capabilities of pharmaceutical and medical device innovation service stations; optimizing and improving the efficiency of review and approval processes; supporting research, development, innovation, and the transformation of achievements; promoting high-quality development of the cosmetics industry; building a digital industrial and smart regulatory system; strengthening talent recruitment, cultivation, and financial support for the industry; deepening international exchanges and market expansion; establishing a comprehensive quality and safety assurance system; and enhancing regional cooperation and industrial linkage.