Recently, Cofoe Medical, a Chinese home medical device company, officially signed a strategic cooperation agreement with Royal Philips. The two parties will engage in in-depth cooperation around various family health monitoring devices, enabling high-quality health technology products to reach more Chinese households. According to the agreement, Cofoe Medical will obtain brand authorization for multiple family health monitoring devices from Royal Philips in China, including blood glucose meters, blood pressure monitors, continuous glucose monitoring systems (CGM), thermometers, pulse oximeters, spirometers, and weighing scales. Both parties will jointly promote the technological research and development, localized adaptation, and iterative upgrades of related products. Cofoe Medical will take full responsibility for the production and manufacturing, brand operation, channel layout, and service system construction of these products in China, achieving a deep integration of innovation in research and development and industrial capabilities.

Recently, at the Tsinghua University Clinical Medicine Science and Technology Innovation Conference, the Tsinghua Clinical Medicine Science and Technology Innovation Platform was officially launched, with the concurrent hosting of the Shuimu Tsinghua Clinical Research Forum. The platform integrates six core entities to establish a comprehensive collaborative innovation system covering the entire chain of "clinical research – clinical translation – pharmaceutical and device development – data science – medical-engineering integration – clinical validation." It enables resource sharing and capability complementation, deeply integrating Tsinghua's multidisciplinary strengths to promote seamless connections from the identification of clinical issues to the transformation of results and industrial application. This addresses challenges in the development of clinical medicine and accelerates the output of new drugs, new devices, and innovative diagnostic and treatment solutions.

Recently, the Beijing Intellectual Property Office released the list of recognized units for the 2025 Beijing Intellectual Property Pilot Advantage Program. Weimai Medical was selected thanks to its "R&D breakthrough - patent fortification - transformation implementation" strategy and over a hundred core patents. Its vascular intervention "eye, hand, brain" collaborative solution breaks through the limitations of traditional interventional robots, achieving "human-machine integration." This system, through full-chain closed-loop design, makes interventional robots an intelligent extension of a doctor's surgical capabilities, achieving key breakthroughs in tactile feedback and motion control. It also fully integrates with the underlying data of DSA equipment, enabling seamless tactile feedback and motion execution. Currently, Weimai Medical has obtained more than a hundred patents, transitioning from "technology follower" to "innovation leader."

On December 8, the Ministry of Industry and Information Technology (MIIT) and the National Medical Products Administration (NMPA) announced the "2025 AI Medical Device Innovation Task - Shortlisted Units for Leadership in Charge." The "Coronary Artery Interventional Surgery Control System," independently developed by Ruixin Healthcare, has been shortlisted in the intelligent auxiliary decision-making product category. This initiative aims to select innovative entities to focus on key challenges and promote the development of AI-powered medical devices. Ruixin Healthcare’s system is applied in percutaneous coronary intervention (PCI) procedures and consists of a slave surgical platform and a master control platform, enabling doctors to precisely control surgical instruments in real time and assist in completing critical steps. Currently, PCI is the most effective treatment for coronary heart disease, but traditional surgery faces challenges such as high operational difficulty, long procedure times, and radiation exposure for doctors, along with uneven distribution of medical resources. Ruixin Healthcare’s system helps doctors avoid radiation, enables precise navigation, assists novice surgeons, and improves the success rate and accessibility of surgeries. To date, the system has filed over 20 patent applications and completed multiple validations.

Wuhan Designates Tongji Hospital as the "Wuhan Brain-Computer Interface Clinical Transformation Technology Innovation Center" Relying Unit

Recently, the National Healthcare Security Administration officially released the "Guidelines for the Establishment of Surgical and Therapeutic Auxiliary Operation Projects (Trial) (Draft for Comments)". Through a multi-faceted strategy involving standardized pricing, regulated management, and market-oriented compatibility, the guidelines remove policy barriers for the clinical popularization of cutting-edge medical technologies. In the field of robotic surgery charges, the Guidelines provide comprehensive and detailed coverage. All auxiliary scenarios throughout the entire process, from navigation and partial execution to precise execution, are included, unifying the pricing framework for robotic-assisted operations across different departments and anatomical locations. This innovative classification method breaks the limitations of traditional categorization based solely on anatomical treatment areas, establishing "surgical robotic arm assistance" as an independent auxiliary operational unit for pricing purposes.

Recently, Beijing has launched a pilot program to establish 26 demonstration and promotion centers for the clinical application of innovative drugs and medical devices, aiming to build a systematic demonstration and promotion system for innovative drugs and medical devices and promote the innovative development of the pharmaceutical industry. Pilot hospitals will carry out clinical applications and standard formulation for newly approved innovative drugs and medical devices in relevant specialties. Eighteen hospitals, including Peking Union Medical College Hospital, Peking University People's Hospital, and Beijing Tongren Hospital, will establish 26 pilot centers across 11 specialties such as endocrinology, oncology, and medical testing. Each center should form a professional clinical application team, develop and improve clinical application management systems, operational guidelines, and data collection standards; conduct clinical applications of newly approved innovative drugs and medical devices, design and implement high-quality post-marketing evaluation studies, systematically collect and analyze data on the effectiveness, safety, convenience, cost-effectiveness, and patient compliance of products in real-world healthcare settings, and produce evaluation reports.

Recently, the Shanghai Municipal Drug Administration released the "Shanghai Drug Administration's Measures for Responsibility Interview on Drug, Medical Device, and Cosmetic Safety." The Measures state that if any of the following eight circumstances occur, drug regulatory authorities at all levels in Shanghai may conduct interviews with the legal representatives, main persons in charge, or relevant responsible personnel of the entities to be interviewed. These eight circumstances include: occurrence of drug, medical device, or cosmetic safety incidents; evidence indicating potential safety hazards that have not been promptly addressed; products found to be non-compliant or showing abnormal results through supervisory inspections or risk monitoring, potentially posing significant safety hazards; a high number of complaints or reports from the public, media exposure, or cases involving assistance with significant impact; submission of false or authenticity-related problematic materials during the application for registration, filing, or other processes; serious defects in the quality management system with inadequate rectification; failure to timely implement product recalls or other risk control measures as required, or implementation being untimely or insufficient; and poor credit risk ratings for drug, medical device, or cosmetic manufacturers according to municipal regulations.

Recently, the Zhejiang Province Medical Device Inspection and Testing Service Alliance——The Medical Device Inspection and Testing Service Alliance of Ningbo Qianwan New Area was inaugurated at the 4th China Ningbo Biomedical Industry Development Conference. The alliance, jointly initiated by four organizations including the Ningbo Customs Technology Center, adheres to the concept of "resource sharing, complementary advantages, coordinated development, and industry service." It integrates various resources to provide enterprises with one-stop, customized inspection and testing services throughout the product lifecycle. With a solid foundation in the medical device industry, Qianwan New Area faces challenges such as scattered testing and low efficiency. After the establishment of the alliance, the Qianwan New Area Branch of the Ningbo Market Supervision Administration will leverage the strengths of member units to shorten testing cycles, reduce costs, and facilitate product registration and market access.

Recently, according to Beijing Chaoyang Market Supervision news, the Beijing Medical Device Review Center has launched a public service guide that integrates policy consultation, process handling, and innovative service resources to help companies operate more efficiently. The core services offer "three essentials": resolving evaluation issues through the "Beijing Device Review Consultation and Appointment System"; establishing dual innovation service stations in the north and south (Beijing Pharmaceutical and Medical Device Innovation Service Stations) for localized support; and enabling the public to access highlights of the center’s work and reform achievements via official channels. For frequently asked questions, the "Quick Reference Package" specifies that inquiries regarding Class II medical device registration and changes should be directed to the telephone line of Beijing Drug Administration's Device Review and Inspection Center; medical device classification determinations can be processed through the "Medical Device Classification Determination Information System," supplemented by Beijing-specific guides such as the "Comprehensive Guide to Classification Determination (2024)."

Starting from January 1, 2026, China will comprehensively ban the production of mercury-containing thermometers and mercury-containing sphygmomanometers. For mercury-containing products that have already obtained medical device registration certificates, the original registration certificates will remain valid within their validity period; if an application for renewal registration is made upon expiration, the validity period shall not exceed December 31, 2025. Mercury-containing products that have been accepted as medical devices will continue to undergo evaluation and approval as medical devices, and those approved for registration will also have a validity period not exceeding December 31, 2025.