Weekly Medical Device News Roundup [June 30 – July 6]: Innovations, Fundings, and Regulatory Updates

Recently, Yan'an University Xianyang Hospital and Roche Diagnostics announced the joint establishment of the "Roche Excellence Demonstration Center." By introducing Roche Diagnostics' "Made in China" achievement — the domestically produced CCM (cobas® connection modules) laboratory automation solution — the center realizes smart innovation in testing, injecting strong momentum into the high-quality development of the hospital. Reportedly, the Roche Diagnostics domestically produced CCM laboratory automation solution introduced this time centers on the domestically produced fully automated chemiluminescence immunoassay analyzer cobas® pro e 801. It connects pre-analytical sample processing systems via a track, integrates with the cobas® infinity intelligent laboratory solution, and is equipped with an automatic review function. This achieves full-process automation and intelligent management of testing, further shortening sample turnaround time, improving laboratory testing efficiency, and ensuring accurate and reliable results. Additionally, the solution incorporates multiple digital and intelligent solutions such as the Smart QC AI real-time quality control solution and i-Manager standardized intelligent laboratory management software, comprehensively ensuring precise, efficient, and reliable test results, thereby benefiting a wide range of patients.

Recently, Haier Kangyang Industry and Shanghai Bangbang Robotics held a strategic cooperation signing ceremony. The two parties will engage in in-depth collaboration in the fields of smart mobility and comprehensive health-care scenario solutions, striving to promote the intelligent and quality-oriented upgrading of China's health-care industry through technological innovation. According to the agreement, the two sides will carry out in-depth cooperation at three levels: product collaboration, joint R&D on mobility scenarios, channel co-construction and service network upgrades, as well as strategy and capital. Together, they aim to create a new product system and scenario-based services covering everything from light mobility to professional mobility solutions. The cooperative products are expected to hit the market in the second half of 2025. Additionally, they will focus on multi-scenario mobility-assistance devices, share product and channel resources, and jointly promote their core high-demand, high-volume, and high value-added categories to quickly enter each other’s markets, achieving mutual benefit and win-win outcomes.

Recently, the official website of the National Medical Products Administration (NMPA) announced the release of measures to optimize the full lifecycle regulation and support the innovative development of high-end medical devices. Among the measures, it was mentioned that innovative domestic products with international leadership and significant clinical application value will continue to undergo a special review process for innovation. This includes further optimizing the innovation review process, enhancing communication between applicants and review experts, and strengthening technical guidance for the research and registration of innovative medical devices. For changes in registration of high-end innovative medical devices, reviews will be conducted under the special review process for innovation. Support will be given to accelerate the market entry of high-end medical devices involved in national-level high-quality development action plans and other industrial policies. Enhanced registration guidance will be provided for "challenge-list" products related to artificial intelligence and biomaterials, along with supporting policies for medical device products based on brain-computer interface technology in coordination with relevant departments. For high-end medical devices approved under conditional terms, specific requirements for conditional approval will be explored.

Recently, the results of a new round of X-ray procurement projects by the Zhejiang Health Commission were announced. This procurement involved 28 sets of mobile C-arm X-ray machines, with a total budget of nearly 42.57 million yuan and a maximum bid limit of 27.7 million yuan. The project required all equipment to come with an original factory warranty service of more than five years. According to the announcement of the bidding results, bids for sections 3, 4, 11, 12, and 13 were invalidated. Other sections were awarded to mobile C-arm X-ray machines from Siemens Healthineers, Xi'an Jizhi, Wandong Dingli, and Puaire, with a total winning bid amount of 17.113 million yuan. The corresponding budget for the winning sections was 33.72 million yuan, with a maximum bid limit of 22.15 million yuan. Among the valid sections, Siemens became the biggest winner with eight devices and a winning bid amount of 13.597 million yuan, at a unit price as high as 1.6995 million yuan. Based on the public information from this Zhejiang procurement project, the procurement was divided into 13 sections, covering more than ten county-level medical institutions, including Xinchang County People's Hospital and Jinyun County People's Hospital in Lishui City. The bidding results were surprising: all bids for sections 3, 4, 11, 12, and 13 were invalidated, significantly reducing the actual procurement scale.

Recently, the National Medical Products Administration held a meeting in Beijing on the co-governance of safety risks in the online sales of "two products and one device." The meeting reported on the investigation of complaints and reports regarding online sales in the second quarter, public opinion monitoring, and the monitoring and handling of illegal activities. The meeting emphasized that all parties involved in online sales should continue to consolidate cooperative governance efforts to prevent and resolve safety risks. Third-party platforms must fulfill their responsibilities, enhance risk identification capabilities, improve risk prevention and control measures, and establish long-term governance mechanisms. Regulatory authorities are required to further strengthen dynamic monitoring and case handling, deepen special governance initiatives, achieve collaborative effectiveness, and promote high-level safety and high-quality development in online sales.

Recently, at the fifth anniversary "Digital Economy Special Session" press conference of Beijing's "Two Zones" construction, the Director of the Beijing Internet Information Office, in response to a question from a reporter of the Beijing News, stated that Beijing continues to focus on the needs of enterprises in the medical field. Building upon the previously released negative lists in five areas such as pharmaceuticals, Beijing will prioritize the medical device sector for developing the second batch of negative lists, providing policy support to facilitate data export for enterprises. According to reports, aligned with the strategic deployment and task arrangements of the city’s "Two Zones" initiative, the Municipal Internet Information Office regards promoting cross-border data flow as a key measure to activate the value of data elements and empower the development of new productive forces. An innovative policy system has been established, centered around "scenario-based, field-level data export negative lists."

China's National Healthcare Security Administration Releases the "Notice on Further Strengthening the Management of Designated Medical Institutions under the Medical Security System," Emphasizing Strict and Practical Oversight of Medical Insurance Funds

NMPA Announces Measures to Optimize Lifecycle Regulation and Support Innovation in High-End Medical Devices