CMDE Publishes 2026 No. 13 Innovative Device Review Notice - 8 Products Enter Green Channel incl

The Center for Medical Device Evaluation (CMDE) published the 'Innovative Medical Device Special Review Application Review Results Public Notice (2026 No. 13)' on August 10, proposing that eight products enter the special review procedure - China's fast-track 'green channel' for breakthrough medical devices. Under the Innovative Medical Device Special Review Program (NMPA Announcement 2018 No. 83), the Innovation Device Review Office organized expert review of the applications, and the eight projects now proceed to public notice.

The eight products span frontier technology domains: a human tumor molecular residual disease (MRD) detection kit (high-throughput sequencing) by Burning Rock; a glaucoma drainage tube by Chengdu Mikes; a transcatheter mitral valve replacement (TMVR) system by MicroPort CardioFlow; a biodegradable magnesium metal embolization microsphere by Chongqing Baimaitengshi; a tumor electric field therapy device by Kunlun Zhiding; a general anesthesia pump system by Shanghai Ruiyiwei; a transurethral implanted prostatic beam nail device by Shanghai Lixiao Medical; and a Brucella antibody detection kit (micro-column gel method) by Zhuhai Langyue Biotech.

The list illustrates the breadth of China's innovation pipeline - from oncology liquid biopsy and structural heart disease to non-invasive tumor therapy, urology, anesthesiology, and infectious disease diagnostics. CMDE emphasizes that entry into the innovative review procedure does not constitute confirmation of safety or effectiveness for registration; applicants must still complete development and submit registration applications, with authorities applying early intervention, dedicated personnel, and scientific review principles while maintaining standards. The continued expansion of the green channel - now in its 13th public notice of 2026 - reflects the NMPA's sustained commitment to compressing time-to-market for genuinely novel technologies with significant clinical value.