Medical Device Weekly Highlights (June 8–14, 2026): Funding Rounds, Product Approvals, and Regulatory Updates

The approval speed for innovative medical devices in Zhangjiang Science City has significantly accelerated. To date, a total of 13 Class III innovative medical devices have been approved for market launch in Shanghai, with 10 originating from Zhangjiang Science City, accounting for more than three-quarters of the total. The number of innovative medical devices approved from Zhangjiang has already surpassed the full-year total of the previous year. Recently approved products include the Shenqi Medical Qilin-M® Transcatheter Mitral Valve Clip System, the Lanmai Medical Fishhawk® Disposable Thrombectomy Device, and the Xuanyu Medical Steerable Pulmonary Artery Embolectomy Stent System, covering high-barrier clinical areas such as structural heart disease, peripheral venous intervention, and interventional treatment for pulmonary embolism. Zhangjiang Pharma Valley continues to liaise with the NMPA Center for Drug Evaluation and Inspection (Yangtze River Delta Branch) and the Center for Medical Device Technical Evaluation and Inspection (Yangtze River Delta Branch), promoting early intervention for innovative drugs and devices, implementing tailored strategies for each enterprise, and providing comprehensive guidance throughout the process.

Innovative RF Medical Device Project Signed and Launched in Suzhou High-Tech Zone: Building Core Product Lines in Aesthetic and Surgical RF with Prominent Patent AdvantagesThe Innovative RF project has been officially signed and established in the Suzhou High-Tech Zone. The company has developed two core product lines—radiofrequency (RF) devices for medical aesthetics and RF surgical systems—highlighting its significant advantages in patented technologies. This project will establish an R&D headquarters and an intelligent manufacturing production base, creating a comprehensive solution platform to achieve full-chain independent control. It aims to enhance the supply capacity of high-end domestically produced RF medical equipment and inject new momentum into the industrial development of the High-Tech Zone.Currently, the Suzhou High-Tech Zone has gathered more than 1,400 enterprises related to medical devices and the broader health industry, with an industrial output value exceeding RMB 50 billion, forming a complete industrial chain characterized by robust vitality. Looking ahead, the Suzhou High-Tech Zone will focus on providing full-lifecycle services for projects, continuously optimize the business environment, strengthen the guarantee of resource elements, and accelerate project construction to ensure early commencement of production.

On June 5, 2026, information from the China National Intellectual Property Administration (CNIPA) revealed that Wuhan Mindray and Shenzhen Mindray are jointly applying for a patent titled “A Field-of-View Display Method and Surgical Robot System,” with an application date of November 27, 2024. In March this year, Mindray officially announced that its surgical robot products would enter the registration phase. Although Mindray is the leading player in China’s medical device industry, it is a newcomer in the surgical robotics sector. The global surgical robotics market is intensely competitive: da Vinci holds a dominant position, while emerging competitors such as Medtronic are making strong inroads. Meanwhile, domestic players like Jingfeng Medical have refined their products, and new entrants are also coming to the fore. Despite the broad applications of surgical robots, their adoption rate remains relatively slow due to high procurement costs and a steep learning curve. Mindray’s new patent primarily addresses the issue of limited assistant visibility during instrument changes in surgical robotics. By employing a “physical pull-back + visual compensation” approach, the solution lowers the threshold for team collaboration and promotes the wider adoption of surgical robots.

On June 10, 2026, Xiangyu Medical held a strategic cooperation signing ceremony with the First Affiliated Hospital of Nanchang University. Representatives from both sides attended, including Liao Lan, Secretary of the Party Committee of the First Affiliated Hospital of Nanchang University, and Cui Lulu, Deputy Secretary of the Party Committee of Xiangyu Medical. The ceremony was presided over by Vice President Huang Xia. Secretary Liao Lan introduced the hospital’s explorations in fields such as brain-computer interfaces, emphasizing that the collaboration represents a deep integration of healthcare and high-end manufacturing. Director Cui Lulu stated that the First Affiliated Hospital of Nanchang University possesses substantial strength, and expressed expectations for breakthroughs in frontier areas. Vice President Li Jianming and Manager Li Yunhua signed the "Strategic Cooperation Framework Agreement" on behalf of their respective parties. Both sides will focus on core directions such as innovative applications in rehabilitation medicine, streamline the complete innovation chain, and inject new momentum into technological innovation in rehabilitation healthcare. Following the signing, the two parties engaged in in-depth discussions on cooperation matters. Xiangyu Medical will take this opportunity to deepen its engagement in relevant fields, empowering the Healthy China Strategy with robust achievements.

China Implements SAMR Announcement No. 14 of 2026: The “One List, One Database” Framework Officially Takes EffectThe nationwide implementation of the State Administration for Market Regulation’s Announcement No. 14 of 2026 marks the official rollout of the “One List, One Database” framework, impacting 53,000 inspection and testing institutions across China and bringing significant transformation to the medical device testing sector. The “One List” refers to the “Access List” for statutory inspection and testing fields, clearly defining 11 major categories that require CMA (China Metrology Accreditation) qualification accreditation, thereby establishing clear qualification requirements for inspection and testing activities. The “One Database” is the “Standard Database” for inspection and testing capabilities, comprising over 45,000 standards to provide a unified basis for capability assessment. For the medical device industry, this framework clarifies compliance boundaries, eliminating the need for “excessive qualifications”; facilitates cross-regional practice by breaking down regional barriers; and promotes fairer market competition, thereby enhancing overall industry quality. Relevant institutions are required to review their existing CMA qualifications against the “One List, One Database” framework to distinguish between items within and outside the list.

Sichuan Provincial Medical Products Administration Releases “Strengthening Quality and Safety Supervision to Standardize the Development of the Medical Aesthetics Industry: Sichuan Comprehensively Fortifies the Safety Defense Line for Medical Aesthetic Drugs, Devices, and Cosmetics” to Regulate the Medical Aesthetics Industry and Safeguard Public Health Rights and Interests. The measures include: First, consolidating the primary responsibility of enterprises and local regulatory oversight, urging companies to conduct self-inspections and self-corrections. Second, closely monitoring high-risk products and strengthening whole-chain control, with a focus on high-risk drugs such as injectable botulinum toxin type A and medical aesthetic devices; strictly defining the operational boundaries between life beauty services and medical aesthetics; and investigating and punishing illegal and non-compliant activities related to cosmetics. Third, deepening collaborative governance by coordinating multi-departmental joint law enforcement and penalties, ensuring accessible complaint channels, implementing individual accountability for penalties, and enhancing the deterrent effect of regulation. Moving forward, the Sichuan medical products regulatory system will continue to carry out routine inspections and rectifications in the field of medical aesthetics, strictly control quality and safety risks, crack down on illegal and non-compliant behaviors, and protect the public’s health and beauty rights and interests.

To implement the Regulations on the Supervision and Administration of Medical Devices, the Measures for the Supervision and Administration of Medical Device Production, and the Good Manufacturing Practice for Medical Devices, and to standardize and guide inspections of medical device production, the National Medical Products Administration has organized the drafting of the Guiding Principles for Inspection of Good Manufacturing Practice for Medical Devices (Draft for Comment), which is now open for public comment. The period for public comment is from June 9, 2026, to June 24, 2026.

The Hospital Authority (HA) of Hong Kong has announced the establishment and operational launch of the Hong Kong Office for Introduction of Innovative Drugs and Medical Devices, in alignment with policy directions. This office will expedite the introduction procedures for “new drugs” and “high-quality drugs,” ensuring their timely inclusion in the HA Drug Formulary, while also proactively introducing cost-effective innovative medical devices. The HA will collaborate with the Department of Health to accelerate the registration process for new products through the “Priority Review Pathway,” significantly shortening the review time for recommended new drugs. The Office for Introduction of Drugs and Medical Devices will proactively identify local patient needs, engage with pharmaceutical companies, review suitable drugs, and arrange for registration. During the registration period, price negotiations and comprehensive assessments will be conducted in advance, with applications for formulary inclusion submitted promptly upon approval. An efficient evaluation channel has already been established for innovative medical devices. The HA is confident that these optimized processes will enhance treatment outcomes and improve patient well-being.

Recently, Lei Ping, a member of the Party Leadership Group and Deputy Director of the National Medical Products Administration (NMPA), led a team to conduct field research in Lanzhou, Wuwei, and other areas in Gansu Province. The team visited users of heavy ion therapy systems, innovative medical device enterprises, and relevant scientific research institutions to gain insights into the innovative research and development of products such as heavy ion therapy systems, their clinical applications, and the progress and implementation of the “Spring Rain Action” for the transformation of clinical innovation achievements in medical devices.

The National Medical Products Administration (NMPA) has issued the "Announcement of the National Medical Products Administration on Matters Concerning the Adjustment of Medical Device Classification" and the "Procedures for the Dynamic Adjustment of the Medical Device Classification Catalog," to further optimize the dynamic adjustment mechanism for the medical device classification catalog. The Announcement further clarifies the requirements for registration and filing following adjustments to the regulatory attributes and classification categories of medical devices, including requirements for registration and filing after changes in management categories, requirements for products reclassified from non-medical devices to those regulated as medical devices, and requirements for products no longer regulated as medical devices after adjustment. The Procedures expand the scope of applicable catalogs to include the "Catalog of Class I Medical Device Products" and the "Catalog of In Vitro Diagnostic Reagents" based on the original "Medical Device Classification Catalog." They also specify the principles, relevant scenarios, and workflow for the dynamic adjustment of the catalogs, marking a new stage in medical device classification management that is more dynamic, scientific, and standardized.

After identifying the causes of quality issues, the Medical Device Authority (MDA) of Malaysia has ordered corrective and preventive actions for multiple products. The MDA mandated testing for six categories of medical devices with high complaint volumes. The complaints involved issues such as surgical blades becoming dull during procedures, eye drops causing allergic reactions, and transfer kits leaking fluid during use. In collaboration with ECRI Berhad, the MDA evaluated multiple hypotheses for each complaint. The testing provided at least one potential explanation for each issue. Degradation of silicone tubing due to prolonged exposure to povidone-iodine explained the leakage in transfer kits, while the lack of coating on the blade surface was identified as a possible cause for the dulling of surgical blades. The MDA has required manufacturers to rectify the issues identified in the testing.