NMPA CMDE publishes Innovation Medical Device Special Review application review results (Public Notice No. 17 of 2026)

On 19 October 2026, the Center for Medical Device Evaluation of China’s National Medical Products Administration published Public Notice of Review Results for Special Review Applications of Innovative Medical Devices (No. 17 of 2026) , proposing five applications for entry into the Special Review Procedure for Innovative Medical Devices. The public comment period runs from 19 October to 2 November 2026.

The five candidates span interventional circulatory support, renal artery ablation, pulsed field ablation, percutaneous cerebrospinal fluid shunting, and tuberculosis drug-resistance gene detection: an interventional left ventricular assist catheter pump kit (Shenzhen Core Medical Technology Co., Ltd.); a renal artery ultrasound ablation device (Mednovo Medical Technology Group Co., Ltd.); a pulsed field ablation device (Zhoulang (Zhongshan) Medical Device Co., Ltd.); a percutaneous interventional hydrocephalus shunt system (Tongqiao Medical Technology Co., Ltd.); and a Mycobacterium tuberculosis complex nucleic acid and drug-resistance mutation detection kit (combined probe-anchored polymerization sequencing) (Tianjin Genis Medical Technology Co., Ltd.).

The special review pathway targets devices that hold a core-technology invention patent in China, represent a domestic-first working principle or mechanism, reach internationally leading technical levels, and offer significant clinical value. Once admitted, applications receive prioritized processing under the principles of early intervention, dedicated personnel, and scientific review—without lowering standards or reducing procedural steps. The notice also sets two explicit limits: this publication is not itself a basis for entry into the innovative review pathway, which depends on the final review conclusion; and entry into the pathway does not constitute a determination that a device’s safety and effectiveness for registration have been established. Whether these five candidates ultimately clear the pathway will come down to the comment period and the subsequent regulatory review.