1. Eight medical devices were denied registration, including five domestic products
In October, the NMPA denied registration for 8 medical device products, including 5 domestic products and 3 imported products, down 27.3% from September. Important devices such as intracranial drug-eluting stents failed to obtain approval,as regulatory scrutiny tightens,insufficient clinical evidence has become the main hurdle. The list includes Kuanteng Medical's X-ray computed tomography equipment, Blue Medical Devices' high-pressure balloon dilation catheter, and others.
2. In October, the NMPA terminated 12 medical device registration applications
In October, the NMPA terminated the registration applications for 12 medical devices. These included Philips' single-level sleep non-invasive ventilator and Suzhou Boying Medical Technology Co., Ltd.'s X-ray computed tomography equipment, among others. The companies involved should pay close attention to applicable regulatory requirements to ensure product quality and safety.
3. China's first Class III ultrasound aesthetic medical device approved
On November 3, Bandao Medical's independently developed third-generation ultrasound anti-aging device, "半岛大超炮," namely a focused ultrasound skin treatment device, obtained an NMPA Class III medical device registration certificate, making it the world's first andcurrently the only Class III ultrasound aesthetic medical device approved for marketing。
4. NMPA Issues Class III Recall Notice
The Jiangsu Medical Products Administration announced a Class III recall. Topoint Medical Device (Jiangsu) Co., Ltd. initiated a voluntary recall of its single-use infusion set for insulin pumps after the product failed to meet the UV absorbance requirement in the 2025 national sampling inspection. The affected batch is TCSF-I-F607, involving 4,950 units, of which 4,920 units were sold.The issue was related to a malfunction of the UV curing equipment during manufacturing, and the company has improved the process and strengthened testing. Relevant customers have been notified to stop using this batch of products.
5. Jiangsu Medical Products Administration Unveils Binhu Review and Inspection Workstation
The Binhu Review and Inspection Workstation of the Jiangsu Medical Products Administration was officially signed and inaugurated in Binhu, Wuxi. Tian Feng, Director of the Jiangsu Medical Products Administration, and Li Ping, Secretary of the Binhu District Party Committee, attended and delivered remarks. The Binhu Workstation will provide services including policy interpretation and business consultation to support the commercialization of innovative achievements by enterprises.
6. Hainan Updates Medical Device Distribution Supervision Rules to Promote Industry Development
The Hainan Medical Products Administration has revised the Detailed Implementing Rules for the Supervision and Administration of Medical Device Distribution in Hainan Province to optimize the business environment and promote high-quality development of the medical device industry. The main revisions include: adjusting the requirements for operating premises and warehouse area for medical device wholesale enterprises so that they are commensurate with the business scope and scale; and strengthening enforcement measures for enterprises that fail to eliminate medical device quality and safety risks, with handling carried out in accordance with relevant regulations. The revised implementing rules will take effect 30 days after publication.
7. Former Deputy Director of the Guizhou Provincial Health Commission Tian Yan Arrested on Suspicion of Bribery
Tian Yan, former Party Leadership Group member and Deputy Director of the Guizhou Provincial Health Commission, was recently arrested by the Anshun Municipal People's Procuratorate on suspicion of accepting bribes. Tian Yan previously served as Director of the Guizhou Provincial Center for Disease Control and Prevention Administration and held multiple key positions. Following the conclusion of the investigation by the Guizhou Provincial Supervisory Commission, she was found to have committed serious disciplinary and legal violations, including violating organizational principles, using her authority to seek benefits for others, and accepting money and valuables. Tian Yan has been expelled from the Communist Party and removed from public office, and the case is under further handling.
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