Medical Device Industry Policy Updates and Product Highlights (March 10–16, 2026)

01

02

03

ROB's "Digestive Endoscopy Surgical Robot" Approved for Marketing

ROB Medical® "Intelligent Orthopedic Surgical Robot 2.0" Approved by NMPA for Official Launch

Soni Cracker™-CL Completes Overseas Product Commercialization Application

Peijia Medical Partners with Yuanfeng Capital to Raise 1.5 Billion Fund, Driving Innovation in Structural Heart Disease, Neurointervention, and High-End Medical Devices; Strong Alliance Sparks Anticipation.

Ozida and Akang Health Sign Strategic Cooperation Agreement to Deepen Collaboration in Multiple Aspects of the Medical Device Industry Chain, Including Services, Technology, Channels, Industry, and Business Innovation, Jointly Promoting High-Quality Development of the Health Industry and Exploring the Path to Popularizing Grassroots Internet Healthcare.

Recently, Boston Scientific, a medical device giant, announced a major acquisition plan. Boston Scientific has reached an agreement to acquire SoniVie, a developer of intravascular ultrasound systems. The total value of this transaction is $600 million (approximately RMB 4.4 billion). Reportedly, SoniVie is a private medical device company that develops the TIVUS™ intravascular ultrasound system. This acquisition will help Boston Scientific enter the highly competitive renal denervation (RDN) market. As a strategic investor in SoniVie, Boston Scientific previously held about 10% of its shares. According to the acquisition agreement, Boston Scientific will pay an upfront payment of approximately $360 million for the remaining 90% of the shares not yet owned. Additionally, if SoniVie achieves specific regulatory milestones, Boston Scientific may pay up to an additional $180 million. Boston Scientific values the upfront payment for this transaction at $400 million, with milestone payments valued at $200 million, bringing the total transaction value to $600 million (approximately RMB 4.4 billion).

China's Medical Equipment Market Reaches 1.35 Trillion Yuan, Forming a Comprehensive Product System. The Ministry of Industry and Information Technology Will Develop the "15th Five-Year Plan" for the Medical Equipment Industry, Promoting the Precision and Intelligence Development of Medical Equipment. Independent Innovation, "Digital Intelligence" Empowerment, People-Oriented, Openness and Win-Win Are the Future Development Paths.

Recently, another significant progress has been made in humanoid robots in Shanghai. Zhiyuan Robotics released the GO-1 large model, a general embodied base model, which has been successfully deployed on multiple robot bodies. Reportedly, GO-1 can utilize human videos for learning and enable robots to adapt to different scenarios and tasks with minimal or even zero samples, lowering the threshold for using embodied models. The foundation consists of large-scale pure text and graphic data from the Internet, helping robots understand general knowledge and scenes. The second layer includes large-scale human operation and cross-body videos, assisting robots in learning human or other body action patterns. The third layer is simulation data, used to enhance generalization and allow robots to adapt to various scenarios and objects. At the top of the pyramid is high-quality real machine teaching data, used for training precise motion execution.

Recently, the Hainan Health Commission announced the centralized procurement results for ultrasound equipment. The total budget of 190 million yuan for 200 sets of equipment was finally completed at 119 million yuan, saving more than 71 million yuan, with a reduction of 37%. This centralized procurement covered 10 categories including obstetrics and gynecology machines, cardiac machines, portable machines, and handheld ultrasound devices. Chinese manufacturers Mindray, Neusoft Medical, and Stork became the biggest winners, while among foreign brands, only GE Healthcare won with its cardiac machine. From the specific winning bids: Mindray Medical exclusively secured 7 bid packages, winning 160 sets of equipment with a total amount of nearly 99 million yuan, accounting for over 83%. Its high-end full-body ultrasound Resona R MV was awarded at a unit price of 795,000 yuan, a decrease of 47% from the budgeted price of 1.5 million yuan, and it is equipped with elastography and AI-assisted diagnostic functions, performing on par with high-end foreign models. Neusoft Medical secured the high-end obstetrics and gynecology machine package at a unit price of 560,000 yuan, a 53% reduction from the budgeted price, with its 4D automatic volume navigation technology breaking the long-term monopoly of foreign companies.

Recently, in order to guide the determination of the regulatory attributes and classification of in vitro diagnostic reagents related to second-generation gene sequencing, the General Office of the National Medical Products Administration has drafted the "Guiding Principles for the Classification of In Vitro Diagnostic Reagents Related to Second-Generation Gene Sequencing (Draft for Comments)" based on the "Regulations on the Supervision and Administration of Medical Devices," "Measures for the Registration and Filing Administration of In Vitro Diagnostic Reagents," "Classification Rules for In Vitro Diagnostic Reagents," and the "Classification Catalogue of In Vitro Diagnostic Reagents." The main scope is that the classification of in vitro diagnostic reagents related to second-generation gene sequencing can refer to this guiding principle. The second-generation gene sequencing technology referred to in this guiding principle, also known as high-throughput sequencing technology, refers to a type of gene sequencing technology with highly parallelized measurement units and relatively short single-read lengths.

Recently, the Inner Mongolia Medical Insurance Bureau announced the notice of the implementation of the centralized volume-based procurement results for cochlear implants organized by the state and pre-filled catheter flushers led by the Inner Mongolia provincial alliance. The single-set price of cochlear implants has dropped from an average of over 200,000 yuan to around 50,000 yuan, marking a 75% reduction. The centralized volume-based procurement of pre-filled catheter flushers is the third provincial alliance procurement led by Inner Mongolia after guidewires and hemostatic materials, with 16 companies selected. The average price reduction is 85.4%, with the highest reaching 93%. After the results for cochlear implants and pre-filled catheter flushers are implemented in the Inner Mongolia region, they will be included in the direct settlement scope between the medical insurance fund and pharmaceutical enterprises, ensuring payment to distribution enterprises by the end of the following month after product warehousing. At the same time, collaborative management of procurement, supply, and usage will be continuously strengthened to ensure that the procurement results truly benefit the public.

Recently, the National Healthcare Security Administration issued the "Guidelines for the Establishment of Neurological Medical Service Price Projects (Trial)", which includes a forward-looking standalone project for brain-computer interface (BCI) new technologies to accelerate the transformation of these technologies into practical applications. It is reported that BCI technology is mainly divided into two categories: non-invasive and invasive. To address the need for continuous equipment adjustments in non-invasive BCIs, the guidelines introduce a new price category called "Non-Invasive Brain-Computer Interface Adaptation Fee". For invasive BCIs, the guidelines establish specific price categories such as "Invasive Brain-Computer Interface Implantation Fee" and "Invasive Brain-Computer Interface Removal Fee". The National Healthcare Security Administration stated that this means once BCI technology matures, a clear payment pathway for rapid clinical application will be ready. After regions implement the guidelines, medical charges for BCIs will have a standardized basis. Additionally, the guidelines set separate "Standard" and "Complex" categories for treatments with high technical value and risk levels; cases recognized by expert consensus as complex can be directly included under the "Complex" category for billing.

Recently, at the 2025 Zhejiang Province Drug, Medical Device, and Cosmetics Regulatory Work Conference, it was announced that Zhejiang will focus on reform and innovation to further optimize the business environment for the drug, medical device, and cosmetics industries. The province aims to accelerate the deep integration of innovation and industrial chains, fostering new momentum for high-quality development in the pharmaceuticals and medical devices sector. To address the difficulties in industrial transformation and upgrading, Zhejiang is implementing a differentiated "one industry, one policy" development strategy, piloting reforms in regions with industrial advantages to create specialized and refined clusters. In areas where the pharmaceuticals, medical devices, and cosmetics industries are concentrated, "group-style" services are being provided to collectively resolve challenges faced by companies in research and development, production, and distribution. So far, Zhejiang's pharmaceuticals, medical devices, and cosmetics industries have shown a "multi-point blooming" trend: Wenzhou’s Eye Valley, Gene Medicine Valley, and Southern Zhejiang Beauty Valley have formed distinctive industrial chains; Huzhou’s cosmetics industry is booming, with its beautiful economy ecosystem maturing continuously; Jiaxing has established grassroots professional regulatory agencies for nuclear medicine, exploring a "Zhejiang solution" for safe nuclear medicine industry development; Taizhou’s Medical Device Town has found breakthroughs in industrial upgrading through differentiated development; Lishui is focusing on nurturing ecological beauty products and traditional Chinese medicine industries, with brand value steadily increasing.

Recently, the General Office of the People's Government of Guangdong Province issued several policy measures to promote the innovative development of the artificial intelligence and robotics industries in Guangdong Province. It mentioned supporting key core technology breakthroughs. Enterprises, universities, research institutes, and other innovative entities are encouraged to conduct joint efforts, forming industrial innovation alliances covering the upstream and downstream of the artificial intelligence and robotics industry chain to accelerate the construction of an end-to-end innovation chain. The province will organize and implement flagship projects and major initiatives under the provincial key R&D program, such as "Next-Generation Artificial Intelligence" and "Intelligent Robots," deploying a series of tasks for breakthroughs in the artificial intelligence and robotics fields. For key projects in the artificial intelligence and robotics sectors that align with national science and technology major projects and meet provincial matching criteria, the provincial finance will provide matching rewards according to regulations. Projects with provincial matching funds exceeding 100 million yuan (inclusive) will be supported through a "case-by-case" approach. An innovation center for manufacturing in the artificial intelligence and robotics sectors will be established, and qualified national and provincial manufacturing innovation centers will receive financial support of up to 50 million yuan and 10 million yuan respectively from the provincial finance.

Recently, eight departments including the Zhejiang Provincial Medical Security Bureau, Zhejiang Provincial Health Commission, Zhejiang Provincial Development and Reform Commission, and Zhejiang Provincial Department of Finance jointly issued a notice regarding the issuance of the "Zhejiang Province Deepening Medical Service Price Reform Pilot Implementation Plan." The core measures and highlights of the "Zhejiang Province Deepening Medical Service Price Reform Pilot Implementation Plan" are mainly reflected in the following aspects: establishing a sustainable total price management control mechanism, optimizing price project management, forming categorized pricing mechanisms, establishing a sensitive and measured dynamic price adjustment mechanism, strengthening comprehensive price governance, improving the price management support system, and promoting the coordinated supporting reform of the three medicals.

Recently, the 2025 Life Valley Synthetic Biology Manufacturing Innovation Seminar was held in Beijing's Changping Future Science City. At the seminar, the Collagen-Based Biomaterials Innovation Consortium was officially launched. The consortium, established by Chang Development in collaboration with the Institute of Process Engineering of the Chinese Academy of Sciences (CAS), universities, and over 20 industry-leading enterprises, brings together more than 20 experts in related fields. It has achieved breakthroughs in more than 10 key technologies, such as collagen self-assembly, leading fundamental and cutting-edge research in collagen protein technology. Additionally, Chang Development has partnered with the Institute of Process Engineering of CAS to establish a biomedical manufacturing innovation platform within the Synthetic Biology Manufacturing Acceleration Center. This platform focuses on critical aspects of the technical chain, including the R&D of biomaterials for medical use, product formulation, and efficacy evaluation, providing key technical support such as third-party testing, pilot-scale trials, animal experiments, and product registration, thereby creating an end-to-end service chain for biomaterials in medical applications.

Recently, according to the information from the National Healthcare Security Administration, the National Healthcare Security Administration has compiled and issued the "Guidelines for the Establishment of Medical Service Price Items for Cardiovascular System (Trial)", for reference.The 2023 edition of the technical specifications for medical service items integrates and maps the current price items and technical specification items for the cardiovascular system into 129 main price items, 53 additional charge items, and 25 extended items. The next step will be to guide the medical insurance bureaus of each province to refer to these, align with actual conditions for implementation, and formulate a unified provincial price benchmark. Regions with price management authority will determine the actual price levels by comparing against the provincial price benchmark, allowing for upward or downward adjustments.

Recently, in order to further standardize the management of government procurement of imported products and support policies favoring domestically produced products, the Nanjing Municipal Finance Bureau issued the "Notice on Strengthening the Management of Government Procurement of Imported Products." First, the Notice requires strengthening the management of demand for the procurement of imported products. For cases where imported products are indeed necessary, the procuring entity should conduct thorough market research to assess the necessity of purchasing the intended imported products, review and refer to the procurement results of similar projects within China and the province, and evaluate whether the technical parameters, price, and performance of domestically produced products meet work requirements. Moreover, for single procurements of imported products exceeding 10 million yuan, market research must be organized to determine if there are domestic agents for the intended products, whether they involve proprietary consumables or exclusive maintenance services, and avoid situations of "low-cost procurement with high-cost maintenance."

Recently, the 2025 Hunan Industrial Belt on Platform Event Changsha Station and Medical Device Special Session Matchmaking Conference was held in Changsha. Over 100 participants from key industrial belt enterprises, cross-border e-commerce platforms, and industry association representatives gathered to discuss how Changsha's medical device industrial belt can "break the waves and sail far" through cross-border e-commerce platforms. According to incomplete statistics, there are currently more than 5,000 companies in Changsha engaged in cross-border e-commerce related businesses. A total of nine cross-border e-commerce industrial parks, three incubation centers, and eleven talent incubation bases have been established, creating a complete development chain and forming an industrial ecosystem of "one core, multiple points, and full regional linkage." At the event, relevant officials from the Changsha Medical Device Industry Go-Global Alliance analyzed how industrial products can leverage cross-border e-commerce brands to expand overseas. The head of Amazon Global Selling Business Purchasing stated that the global medical device market size will continue to grow, with current popular product categories including home medical devices and home test kits.