1. NMPA issues 15 standards
2. NMPA adopts new version of the Drug Manufacturing License
On October 30, the NMPA issued a notice (药监综药管〔2025〕63号) stating that, effective January 1, 2026, the revised Drug Manufacturing License will be put into use. Both the original and duplicate copies will carry unique QR codes, while existing licenses may continue to be used until their expiration dates.
3. Suzhou launches 2025 centralized procurement for medical equipment
Suzhou has launched its 2025 centralized procurement of medical equipment. The plan allocates RMB 269 million for the bulk purchase of 119 imaging systems, including CT, MR, DSA, DR, and ultrasound. This procurement round emphasizes domestic substitution, with several lots explicitly excluding imported products, supporting the growth of domestic brands in the primary care market. This marks the third consecutive year of large-scale centralized procurement in Suzhou, aiming to generate fiscal savings through scale effects and improve the efficiency of medical-equipment allocation.
4. Q3 2025 medical-device results released
Q3 2025 results for medical-device companies have been released, with Mindray and United Imaging leading the field. Mindray's Q3 revenue increased 1.53% year on year, marking an inflection point, while its international business posted strong growth. United Imaging Healthcare reported revenue growth of 27.39% year on year for the first three quarters, with net profit surging 66.91%. Multiple companies, including Winner Medical and Lepu Medical, achieved simultaneous growth in revenue and net profit. Overall, domestic medical devices delivered stable performance, with international expansion and technological innovation serving as the main growth drivers.
5. Sinopharm medical-device subsidiary penalized for failure to supply after winning bid
A Sinopharm medical-device subsidiary has been penalized. In the procurement project for “ultra-high-end color Doppler ultrasound equipment for Shuangdun Central Health Center,” Sinopharm Holding Medical Equipment Anhui Co., Ltd. declined to sign the contract after winning the bid, citing the manufacturer's inability to supply. The Changfeng County Finance Bureau determined that the conduct was unlawful and, under the Government Procurement Law, imposed a fine of 0.5% of the project procurement amount (RMB 1.9 million), totaling RMB 9,500. The penalty serves as a warning that companies must treat bid commitments seriously.
6. AI + healthcare innovation seminar held successfully
The AI + Healthcare Frontier Seminar was successfully held during the Innovation and Entrepreneurship Competition. Experts noted that AI is reshaping medical-device R&D and clinical application. Tianjin has established a fast-track review pathway for AI products, reducing review timelines to an average of 40 days. Industry forecasts indicate a 13% compound annual growth rate for China's medical-device market, with digital and intelligent transformation seen as key to leapfrogging development. Going forward, large AI models are expected to deeply empower surgical robots and drive high-quality industry development.
7. 2024 revenue data released for 20 hospitals in Chongqing
Revenue data for 20 municipal-level hospitals in Chongqing for 2024 have been released. The First Affiliated Hospital of Chongqing Medical University ranked first with total revenue of RMB 7.353 billion, followed by the Second Affiliated Hospital of Chongqing Medical University and Chongqing University Cancer Hospital. Among them, the cancer hospital recorded 24.2% annual growth in revenue and expenditure after receiving RMB 1.65 billion in government fund appropriations. The data also show notable growth at institutions including the People's Hospital Affiliated to Chongqing Three Gorges Medical College and the University Town Hospital Affiliated to Chongqing Medical University, reflecting continued strengthening of regional healthcare capacity.
8. B. Braun Medical invests USD 20 million to expand its U.S. plant
B. Braun Germany has announced a major investment: it will invest US$20 million (approximately RMB 142 million) to expand its manufacturing facility in Pennsylvania, USA. The project is expected to create at least 200 new jobs over the next three years while retaining more than 1,700 existing positions. The Pennsylvania state government will provide US$1.5 million in financial support. B. Braun stated that the expansion is intended to increase production capacity to meet demand for medical devices from healthcare institutions across the United States.
9. Health Canada Class II Recall of Novo Nordisk Diabetes Drug
Health Canada has issued a Class II recall involving Ozempic (semaglutide) pre-filled injection pens manufactured by Novo Nordisk. The recall was initiated because some glass cartridges may have cracks, which could lead to drug leakage, affect dose accuracy, and consequently result in poor glycemic control. This is a precautionary recall, and no related adverse event reports have been received to date. Consumers are advised to inspect the product and contact the manufacturer if any issues are identified.
10. Health Canada Class II Recall of Multiple Ultrasound Systems
Health Canada has issued a Class II recall involving multiple ultrasound systems from BK Medical, including Flex Focus, bkActiv, bkSpecto, and the 5000 series. The recall was initiated because the device user manuals and service manuals do not adequately describe battery replacement intervals, disposal procedures, and safety precautions, creating a potential safety risk. This recall is directed to healthcare institutions, and users are advised to contact the manufacturer for more detailed information.
11. FDA Class I Recall of Dexcom Blood Glucose Monitoring Android App
The FDA has issued a Class I recall involving the Dexcom G6 blood glucose monitoring Android app. Due to a software defect, version 1.15.0 may unexpectedly close, preventing users from receiving glucose readings and high/low glucose alerts, with serious risks including ketoacidosis. A total of 333 units in the United States are affected, and an urgent notice has been issued. This version was discontinued as of October 6, and users must upgrade immediately to the latest version of the app to ensure safe use.
12. FDA Class II Recall of Spacelabs Cardiology Information System
The FDA has issued a Class II recall of the Sentinel V11 cardiology information system from Spacelabs due to a software design issue. Software version 11.6.0 presents a risk of patient information mix-up, which could result in data from a previous patient being incorrectly carried forward or ECG test data being stored in another patient's record. A total of 142 devices worldwide are affected, and an urgent notice has been issued. A corrective patch is expected by the end of September, and version rollback is not currently possible. Users are required to post warnings and confirm receipt of the notice.
13. FDA Warns Philips Over QMS Violations
The FDA has issued a warning letter to Philips, identifying serious Quality Management System (QMS) violations at three of its medical device manufacturing facilities located in Washington State, Pennsylvania, and Eindhoven, the Netherlands. The issues include inadequate oversight of outsourced complaint handling services, incomplete complaint records, distribution of ultrasound probes beyond their service life, failure to initiate corrective and preventive actions as required, and failure to timely report device corrections and removals. The FDA has required Philips to take immediate corrective action or face potential enforcement measures such as product seizure, injunction, or fines.
14. Abbott Class I Recall of Implantable Left Ventricular Assist System
According to information published on the NMPA website, Abbott has voluntarily initiated a Class I recall of its implantable left ventricular assist system because excessive manipulation of the connector interface may trigger the backup battery alarm. This issue may affect normal device operation and presents a high safety risk.
15. Boston Scientific Class III Recall of Biliary-Pancreatic Endoscope Catheter
According to information published on the NMPA website, Boston Scientific has voluntarily recalled specific lots of its single-use biliary-pancreatic endoscope catheter, SpyScope DS II, in India due to incorrect manufacturing site information on the product label. This is a Class III recall. The issue does not affect product performance and is not expected to cause adverse health consequences.