Recently, Yuwell Medical, a leading medical device company in China's A-share market, delivered a solid "mid-term report card," achieving a revenue of 4.659 billion yuan in the first half of 2025, representing a year-on-year increase of 8.16%, and a net profit attributable to shareholders of 1.203 billion yuan, up 7.37% year-on-year. While its core business maintained steady growth, Yuwell Medical actively embraced the new wave of AI, continuing to intensify its "AI + healthcare" strategy. At the "AI + Future of Health" new product launch event in April this year, the company unveiled more than 30 innovative products and launched the "AI Agent Health Manager," built on its self-developed large model, promoting the deep integration of digital intelligence technology with medical devices. Notably, the interim report disclosed Yuwell Medical's new strategic planning for the future, focusing on three main areas: globalization, digitalization, and wearables. In this regard, Yuwell Medical Chairman Wu Qun stated, "The company will continue to explore new forms of productivity, leveraging AI to assist in research and development, production, and management, achieving the 'hospital-to-home and home-wearable' transformation of products."

Recently, Mindray's Breast Ultrasound Auxiliary Assessment Software has passed the review of the National Medical Products Administration and officially entered the special review process for innovative medical devices. Based on artificial intelligence technology, this product is the AI-assisted diagnostic tool in China’s breast ultrasound field to enter the Class III Innovative Medical Device Special Review Process. Through a standardized intelligent workflow, the product achieves precise BI-RADS assessment and classification (Category 2, Category 3, Category 4A, Category 4B, Category 4C, Category 5) of breast lesions across multiple cross-sections, enhancing the accuracy of early breast cancer diagnosis and promoting the development of equitable healthcare quality. Using the "Expert Consensus on Quality Control for Breast Disease Ultrasound Examination (2019 Edition)" as a benchmark, Mindray utilizes images covering real clinical scenarios and expert diagnostic results as training data and the gold standard. By employing innovative deep learning algorithms, the software integrates clinical knowledge and the image interpretation experience of senior doctors into the auxiliary diagnostic model, enabling efficient and accurate clinical classification even when dealing with complex lesions.

Recently, Haier Biomedical disclosed its semi-annual report for 2025, stating that during the reporting period, it achieved operating revenue of 1.196 billion yuan, with a net profit attributable to shareholders of the listed company amounting to 143 million yuan. The life sciences and medical device industries are entering a critical period of digital and intelligent transformation. Sub-sectors such as low-temperature storage, smart medication management, and laboratory intelligence are benefiting from policy dividends in China, including the deepening of tiered medical treatment and increased investment in biopharmaceutical R&D, while also meeting the demand for upgrading medical infrastructure in emerging overseas markets. Driven by "the synergy of four major industries + AI technology empowerment," Haier Biomedical is building a differentiated competitive barrier. In the blood technology industry, leveraging its first-mover technological advantage, the company holds over 50% market share in plasma collection solutions. During the reporting period, Haier Biomedical further launched self-developed new products such as disposable leukocyte reduction plastic blood bags and fully automatic whole blood component separators, evolving its business model from "single equipment sales" to "intelligent devices + basic consumables + software platforms + value-added services," which not only enhances customer stickiness but also raises the profitability ceiling.

Recently, the Hebei Province Drug and Medical Consumables Bidding and Procurement Management System released the "Notice on Carrying Out Price Linkage for Medical Consumables Listing." According to the Notice, relevant companies should promptly verify the listed product prices. If there is a lower provincial platform listing price (excluding centralized bulk procurement winning prices and negotiated prices), please submit a price reduction application by logging into the Hebei Drug and Medical Consumables Bidding and Procurement Management Subsystem via the "Enterprise Appeal" function before September 15, 2025. Products that fail to actively align with the lowest provincial listing price in China will be suspended from listing upon verification, and will be handled according to the relevant credit evaluation regulations. In addition to issuing the notice on linking listed consumables, Hebei also issued a document adjusting the listing prices of three medical consumable products, including the single-channel implantable deep brain stimulation pulse generator kit. This involves two companies and three products.

Recently, the Beijing Municipal Medical Products Administration will rely on the national platform and launch a series of themed publicity campaigns through the joint efforts of municipal and district-level drug regulatory authorities to build a co-governance and shared drug safety governance model. During the event, Beijing will release provincial compliance guidelines for biopharmaceutical enterprises. This publicity week, themed “Drug Safety: Regulation for the People,” will showcase the achievements of drug regulation work and popularize knowledge about the safety of drugs, cosmetics, and medical devices ("two products and one device"). In terms of cross-regional cooperation, the city will actively participate in the exchange of cutting-edge developments in the biopharmaceutical field within the Beijing-Tianjin-Hebei region and explore innovative regulatory models; host an open day at the National Medical Products Administration’s laboratory, organizing university students in Beijing to visit the Science Popularization Exhibition Hall and laboratories of the Beijing Institute for Drug Control to uncover the mysteries of the lab and experience the power of technological support; the "Policies into Parks" initiative will precisely meet industry needs, serve enterprise development, conduct promotional sessions on innovative policies for drugs and medical devices, release provincial compliance guidelines for biopharmaceutical enterprises, and establish a platform for policy alignment and project collaboration.

Recently, the Hebei Provincial Medical Security Bureau issued the "Notice on Standardizing the Pricing of Radiotherapy Medical Services." The main contents include the addition of 15 new medical service pricing items such as "formulation of radiotherapy plans," and 27 items for additional/supplementary charges. Seventy-two medical service pricing items, including "131Iodine - Hyperthyroidism Treatment," have been discontinued. "Extra-long target area" refers to a linear accelerator electron beam field larger than 20×20cm and an X-ray beam field with one side exceeding 40cm. "Ultra-high dose rate radiotherapy" refers to a method of irradiating the tumor target area using an ultra-high dose rate (≥40 Gy/s). "Adaptive radiotherapy" refers to a technique that dynamically adjusts the radiotherapy plan based on tumor regression during the treatment process. "Motion management" refers to limiting, tracking irradiation, or controlling machine beam output at specific phases of periodic motion for tumor target areas using technologies such as implanted gold markers, optical surface monitoring, and respiratory control. This will take effect starting from October 15, 2025.

Recently, the "Notice of Shaanxi Province on Integrating and Standardizing Medical Service Price Items for Radiological Examinations" has been officially implemented. The cost of film consumables for radiological imaging examinations is no longer bundled into the examination fees, and the routine physical film printing service has been completely canceled. Imaging data will be provided to patients in the form of digital imaging (cloud imaging). After this integration, the original items have been significantly reduced. Meanwhile, additional charges and extended items have been set up to account for different resource consumption in various scenarios (e.g., equipment differences, technical difficulty) for the same examination — making price calculation clearer, execution more uniform, and better reflecting the technical labor value of medical staff while adapting to the development needs of new technologies such as CT and MRI. This price adjustment strictly follows the principle of "reducing material costs and increasing labor," reducing the prices of seven categories of equipment-material-based examination items, including X-ray photography, magnetic resonance (MR) plain scan, and PET/CT, to meet the target range required by the state. Overall, the prices of radiological examinations across China have stabilized with a slight decrease, which is expected to significantly reduce the examination cost burden on patients.

Recently, the Beijing-Tianjin-Hebei region officially announced the launch of a volume-based joint procurement of medical film consumables, and information consolidation work has now commenced. The "3+N" large-scale alliance in the Beijing-Tianjin-Hebei region is further enhancing and expanding its centralized procurement efforts by initiating volume-based joint procurement of medical film consumables. According to the Notice, the medical insurance classification and code for medical films covered in this information maintenance include, but are not limited to, products starting with C14020225900006. Additionally, the medical films involved in this information maintenance are divided into two product categories: laser films composed of polyester (PET) base coated with silver halide and protective layers; and thermal films consisting of polyester (PET) base, thermal layer, and protective layers. Inkjet printing films, toner printing films, and office laser printing films are not included.

Recently, the State Council approved the "Comprehensive Innovation Development Plan for the Biomedical Industry Chain of the China (Jiangsu) Pilot Free Trade Zone." The plan was released on the Ministry of Commerce's official website on the same day. Leveraging the industrial foundation advantages of the Jiangsu Pilot Free Trade Zone, the plan focuses on enhancing biomedical R&D and innovation capabilities, improving product approval services, establishing a biomedical production and distribution system, refining procurement and usage policies for biomedical products, and increasing support and security for key elements. It outlines 18 key tasks across seven areas to promote integrated innovation throughout the entire chain. The plan aims to achieve rapid growth in the scale of the biomedical industry in the Jiangsu Pilot Free Trade Zone by 2030, with continuous optimization of the innovation ecosystem, significant improvement in the modernization level of the industrial chain, substantial enhancement in the level of openness, continuous strengthening of security capabilities, breakthroughs in key technologies, and the cultivation of distinctive and competitive industrial clusters in key areas such as large-molecule biopharmaceuticals, cell and gene therapy, and innovative medical devices.

Recently, Jiangsu Province has comprehensively promoted in-depth reform in the regulation of pharmaceuticals and medical devices to facilitate high-quality development of the pharmaceutical industry, introducing policy measures. Optimization of medical device registration and licensing. For group enterprises that meet the criteria and have registered products domestically coming to Jiangsu for application, technical review will be completed within 5 working days. Simplification of registration application materials for low-risk category products. Concurrent review and approval for Class II medical device pre-market registration and production license applications, with renewal and change registration matters handled together. The average inspection timeframe for powered medical devices has been shortened from 85 working days to 60 working days. Priority will be given to arranging registration inspections, supplementary inspections, technical reviews, and system verifications for the first-in-China, innovative, emergency, and priority Class II medical devices. Medical device manufacturers with no critical non-conformities and no major changes in their quality management systems within two years will be issued production licenses after document review. Optimization of import declaration processes for medical device components and validation samples, simplification of rework procedures for exported medical devices, allowing companies to associate with the original customs clearance process.

Recently, Fujian Province issued the "Work Plan for Implementing the Opinions on Comprehensively Deepening the Reform of Drug and Medical Device Regulation to Promote High-Quality Development of the Pharmaceutical Industry." The Work Plan emphasizes the implementation of joint development initiatives for drug and medical device clinical trials. It supports the establishment of several clinical research consortia led by national or provincial laboratories, national regional medical centers, and high-level hospitals, guided by clinical needs. These consortia will focus on fields of advantageous disciplines to conduct high-level clinical research with translational potential. It encourages qualified tertiary medical institutions to actively register as clinical trial institutions, expanding resources for drug and medical device clinical trials. Strengthening the capacity building for clinical research support, it supports high-level hospitals in recruiting clinical research talent, promotes the construction of research-oriented wards and enhances research capabilities, and improves fast-track mechanisms such as ethical review and project initiation review. Support is given to establish an innovative drug and medical device clinical trial exchange platform, organizing legal and regulatory training, innovative drug and medical device project matchmaking, and sharing experiences in clinical trials. High-level clinical trial institutions are encouraged to actively undertake innovative drug and medical device projects, as well as multi-center clinical trial projects both internationally and domestically. The support provided by public hospital clinical trial institutions for conducting clinical trials of innovative drugs and medical devices will be included in the annual performance appraisal of public hospital directors.

Recently, the Qinghai Provincial Drug Administration, in collaboration with 10 local departments, introduced Qinghai's "Several Measures on Comprehensively Promoting the Reform of Drug, Medical Device, and Cosmetic Regulation to Facilitate High-Quality Development of the Pharmaceutical Industry." Focusing on encouraging innovation and R&D, optimizing review and approval processes, enhancing regulatory efficiency, and building a drug, device, and cosmetic safety supervision system, the measures propose 16 reform initiatives to inject new momentum into the development of the plateau drug, medical device, and cosmetics industry. In terms of encouraging innovation and R&D, the measures emphasize supporting the R&D of innovative drugs, devices, and cosmetic ingredients through a working mechanism of "early intervention, tailored strategies for each enterprise, full-process guidance, and research-review coordination." The measures also promote the enhancement of provincial Chinese medicine (including ethnic medicines) standards, initiate the selection and database construction of "Famous Qinghai Prescriptions," and accelerate the establishment of a Tibetan medicine processing technology heritage base. Additionally, enterprises and research institutions are encouraged to develop plateau-characteristic medical devices guided by clinical value. Efforts will also focus on building the "Beautiful Qinghai · Pure Beauty" brand, establishing and improving the "List of Qinghai Characteristic Cosmetic Ingredients," and enhancing the quality and competitiveness of plateau-characteristic cosmetics.

Recently, the Shenzhen Market Supervision Administration organized a city-wide roadshow selection event for key innovative medical device projects. The event aims to identify high-quality projects capable of breaking through technological bottlenecks, addressing clinical pain points, and driving industrial upgrading. By focusing on three core dimensions—"originality, clinical value, and market potential"—the roadshow projects, including high-end medical devices, implantable and interventional products, and in vitro diagnostic reagents, were thoroughly analyzed and objectively evaluated. A relevant official from the Shenzhen Market Supervision Administration stated that they hope to precisely select "hard-tech" projects with originality, breakthrough potential, and significant clinical value—projects that can address major clinical needs, fill domestic gaps in China, or break foreign monopolies—and provide one-on-one pre-market services to accelerate the product launch process.

Recently, the Malaysian Medical Device Authority (MDA) and the Singapore Health Sciences Authority (HSA) jointly launched a pilot program aimed at accelerating the market entry of Class B, C, and D medical devices in both countries. The pilot will officially commence on September 1, 2025, and run until February 28, 2026. This initiative represents an important step in deepening regulatory cooperation for medical devices between the two countries, with the goal of achieving faster approval processes, reducing duplicate reviews, and enabling patients to access safe, innovative, and high-quality medical devices sooner by leveraging mutually recognized evaluation and approval outcomes. Under the pilot arrangement, medical devices already registered with Singapore’s HSA can undergo a "verification pathway" via conformity assessment bodies (CABs) under Malaysia’s MDA. The evaluation time will be significantly shortened from the standard 60 working days required for full conformity assessment to just 30 working days, followed by registration completion within 30 working days. Similarly, medical devices registered with Malaysia’s MDA can enjoy simplified evaluation in Singapore’s HSA, with the review time for all Class B to D medical devices expected to be reduced by 30% overall.

On September 2, the National Medical Products Administration (NMPA) announced on its official website the development plan for the recommended medical device industry standard "Performance Testing Methods for RACA Robotic Motion Intention Encoding and Decoding in Medical Devices Using Brain-Computer Interface Technology" (see figure below). During the announcement period, if there are any objections, please provide feedback to the NMPA.