China NMPA CMDE Public Notice: Eight Innovative Medical Devices Proposed for Special Review

On September 9, 2026, the Center for Medical Device Evaluation of the National Medical Products Administration issued the “Public Notice on Review Results of Applications for Special Review of Innovative Medical Devices (No. 15 of 2026).” In accordance with the Special Review Procedure for Innovative Medical Devices (NMPA Announcement No. 83 of 2018), the Innovative Medical Device Review Office organized relevant experts to review applications for special review of innovative medical devices and proposes to agree that eight applications enter the special review procedure. The public comment period is from September 9 to September 23, 2026.

The proposed projects include: Bladder Endoscopic Surgical System, applied by Guangzhou Qiaojieli Medical Technology Co., Ltd.; Implantable Wireless Brain-Computer Interface System, applied by Beijing Zhiran Medical Technology Co., Ltd.; Liquid Embolic Agent, applied by MicroPort NeuroTech (Shanghai) Co., Ltd.; Single-use Magnetic Localization Pressure Monitoring Radiofrequency Pulsed Ablation Catheter, applied by St. Jude Medical; Temperature-sensitive Liquid Embolic Agent, applied by Guangdong Guangna Anliao Technology Co., Ltd.; Deep Brain Macro-Micro Electrode, applied by Beijing Huake Hengsheng Medical Technology Co., Ltd.; Aortic Arch Single-Branch Stent Graft System, applied by Lifetech Scientific (Shenzhen) Co., Ltd.; Human Homologous Recombination Repair Deficiency Detection Kit (Combinatorial Probe-Anchor Synthesis Sequencing Method), applied by PriMatrix Biopharma (Suzhou) Co., Ltd.

During the public comment period, any entity or individual with objections may submit written objections to the email address of the Center for Medical Device Evaluation of the National Medical Products Administration: gcdivision@cmde.org.cn. Special notes: this public notice does not serve as the basis for the above devices to enter the innovative review procedure, and whether they enter is subject to the final review conclusion. Entering the innovative review procedure does not mean that the product has been recognized as safe and effective for registration approval. Applicants still need to carry out R&D and submit registration applications as required. NMPA and relevant technical institutions will conduct review and approval under the principles of early intervention, dedicated personnel, and scientific review, without lowering standards or reducing procedures.