Medical Device Weekly Highlights (April 20–26, 2026): Innovations, Approvals, and Strategic Investments

Recently, SaintRay Biotech, the IVD leader, made two major investments within three days to accelerate the construction of a life science technology platform. First, it announced an investment of 90 million yuan in Zhe Yuan Technology, an AI healthcare company. Then, it proposed to establish a joint venture to acquire Wasun Micro, with a total transaction price of 93.3929 million yuan. Wasun Micro owns proprietary intellectual property rights for infrared fluorescence enhancement technology and has developed multiple test kits and supporting instruments, covering various fields and obtaining several certifications. Although currently still in the early investment stage with poor financial data, SaintRay Biotech values its technical complementarity and business synergy. Infrared fluorescence technology can complement SaintRay's existing products, and its equipment characteristics align with the company’s strategy to focus on consumer and primary healthcare. Additionally, despite SaintRay Biotech’s recent stabilization in revenue, its profits have declined due to the increase in VAT rates and centralized procurement policies, which might prompt the company to expedite its strategic transformation.

Recently, GE Healthcare's Intelligent CT Detector "Dark Light" Demonstration Production Line officially launched at its Beijing facility, marking a new leap in the intelligent manufacturing capabilities of high-end medical equipment in China. The Beijing site has full domestic production capability, covering everything from complete systems to key components. This newly launched "Dark Light" demonstration line deeply integrates automated equipment, robotics, AI, and IoT technologies, overcoming challenges in micron-level process precision. It achieves automated operation of production processes and intelligent interaction of information flow, eliminating manual operation errors while improving quality, efficiency, and delivery capabilities. This "AI + Intelligent Manufacturing" model sets a new benchmark for the digital and intelligent upgrade of China's high-end medical equipment manufacturing, driving the supply and industrial chains of China's healthcare industry further into the global value chain.

Recently, Beijing Tongren Hospital and Johnson & Johnson China signed a strategic cooperation memorandum to jointly build an innovation and technology cooperation center. Focusing on the clinical application transformation of cutting-edge ophthalmic technologies, academic exchange, and talent cultivation, the collaboration aims to create a medical innovation ecosystem from research to clinical practice. Both parties will work together to establish an academic exchange and training platform covering all of China and radiating across the Asia-Pacific region, promoting the dissemination of new diagnostic and treatment technologies as well as standardized clinical pathways, and enhancing the clinical technical capabilities of ophthalmologists. They will also jointly advance clinical evidence-based medical research, transforming practical experience into scientific achievements. Additionally, they will set up an "integration of medicine and engineering" innovation incubation and transformation platform to empower industrial R&D and explore pilot pathways. Relying on its academic strength and clinical data, Tongren Hospital will collaborate with enterprises to create an all-scenario medical ecosystem and a full-chain R&D transformation system; Johnson & Johnson will integrate its global R&D experience with Tongren Hospital's clinical practice to accelerate the clinical application transformation of cutting-edge technologies.

Recently, the 2026 Guangdong Province "Two Products and One Device" Safety Monitoring Work Conference and Business Training was held in Huizhou, with 95 participants in attendance. The meeting conveyed the spirit of national and provincial drug supervision and management work conferences, reviewed achievements from 2025, analyzed current challenges, and outlined key tasks for 2026. The conference included monitoring business training sessions and experience-sharing among multiple municipal-level monitoring institutions. The meeting emphasized that 2026 should focus on people's health, with modernizing regulatory services as the main goal, achieving "three transformations." Provincial and municipal monitoring institutions are to collaborate closely, reinforce corporate responsibility, promote the development of enterprise training platforms, and strengthen coordination with health authorities. Efforts will also include improving information platforms, innovating regulatory methods, increasing professional training, and leveraging informatization, provincial-municipal cooperation, and technical support to advance Guangdong’s regulatory modernization to the forefront in China.

Recently, according to the arrangements in the "Notice of the Office of the Sichuan Provincial Drug Administration on Carrying Out the 2026 Medical Device Quality Inspection Work," the Sichuan Provincial Drug Administration has formulated the "2026 Sichuan Province Medical Device Quality Inspection and Testing Plan." It mentions that if the sampled unit or the indicated medical device registrant, notifier, or agent of imported products has objections to the test results, they should submit a reinspection application to the Sichuan Provincial Drug Administration within 7 working days from the date of receiving the test report. The Sichuan Provincial Drug Administration will designate a reinspection agency and provide the "Sichuan Province Medical Device Sampling Reinspection Notice." Reinspection applications submitted after the deadline will not be accepted, and failure to request reinspection within the specified time will be deemed as abandonment of the reinspection. The testing agency shall provide the sample within 5 working days from the date of receiving the reinspection agency’s sample transfer notice, submit the "2026 Sichuan Province Medical Device Quality Inspection and Testing Plan" along with the original testing process, result determination basis, and other materials. The samples should be transferred carefully and securely in accordance with product storage and transportation conditions.

Recently, the National Healthcare Security Administration (NHSA) stated at the "Price Establishment for People's Welfare" media briefing that the NHSA firmly supports clinical innovation technologies and continuously promotes the rapid integration of advanced new technologies and products into clinical practice, achieving large-scale applications. During the process of drafting project guidelines, the NHSA has been closely monitoring innovations in the healthcare industry, focusing on projects that fill diagnostic and treatment gaps and represent cutting-edge technology. So far, more than 180 new price items related to new technologies and products have been added, covering areas such as surgical robots, remote surgery, and proton therapy. These pricing initiatives are considered a crucial step in bridging medical technology from research and development to clinical application, helping stabilize market return expectations for innovative companies. It was also revealed that the NHSA is exploring the establishment of a pre-project pricing system for medical services, providing price policy guidance during the clinical trial phase for new technologies and products, facilitating quicker price determination after approval, accelerating the market transformation of high-level innovative achievements, and promoting high-quality development in medical technology.

Recently, the National Center for ADR Monitoring of Medical Devices released the "Key Points for Medical Device Vigilance Inspection" (Trial), which applies to medical device registrants, record-filers, and domestic responsible persons for imported medical devices. It will be piloted in 17 provinces including Beijing, Hebei, and Shanxi. The document focuses on six key dimensions: vigilance system documentation and records, organization and personnel, vigilance planning, data collection reporting and evaluation, risk control, and post-marketing safety evaluation. It establishes 18 inspection points, each with clearly defined requirements and inspection content, to guide regulatory authorities in conducting on-site inspections of companies’ vigilance system establishment, staffing, plan implementation, data management, risk handling, and post-marketing evaluation, thereby strengthening the whole lifecycle safety regulation of medical devices.

In order to further strengthen the guiding role of medical device registration review guidelines in the registration application and technical review process, our center has organized and formulated a compilation plan for medical device registration review guidelines (see attachment for details), which is now released. We hope that medical device industry-related production enterprises, industry associations, research institutes, and other units will pay attention to the specific notices or opinion solicitations regarding the formulation of various guidelines by our center, and actively participate in the formulation and revision of medical device registration review guidelines.

According to the arrangements in the "Notice of the Office of the Sichuan Provincial Medical Products Administration on Carrying Out the 2026 Medical Device Quality Sampling Inspection," the Sichuan Provincial Medical Products Administration has formulated the "2026 Sichuan Province Medical Device Quality Sampling Inspection Plan." It mentions that if the sampled unit or the indicated medical device registrant, record-filer, or agent of imported products has objections to the test results, they should submit a reinspection application to the Sichuan Provincial Medical Products Administration within 7 working days from the date of receiving the test report. The Sichuan Provincial Medical Products Administration will designate a reinspection agency and provide the "Sichuan Province Medical Device Sampling Reinspection Notice." Reinspection applications submitted after the deadline will not be accepted, and failure to request a reinspection within the specified time will be deemed as abandonment of the reinspection. The testing agency shall provide the sample within 5 working days from the date of receiving the reinspection agency's sample transfer notice, and submit the "2026 Sichuan Province Medical Device Quality Sampling Inspection Plan" along with the original testing process, result determination basis, and other materials. The samples should be transferred cautiously and securely according to product storage and transportation conditions.