NMPA Releases 2026 No. 12 Innovative Medical Device Special Review Public Notice

On July 15, 2026, the Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration (NMPA) published the Public Notice of Review Results for Innovative Medical Device Special Review Applications (2026 No. 12), proposing to admit nine innovative projects into the priority review pathway, with a public comment period from July 15 to July 29.

The selected projects span multiple cutting-edge fields including neuro‑intervention, cardiovascular, digestive surgery, neuromodulation, ophthalmology, and radiation oncology. The list comprises a disposable intracranial artery imaging catheter from Shenzhen Mingsi, a self‑expanding intracranial rapamycin‑eluting stent from MicroPort NeuroTech, a coronary covered stent system from Shanghai MicroPort, an implantable left ventricular assist system from Shenzhen Core Medical, a pancreaticojejunostomy drainage stent from Hangzhou Shengshi, an implantable hypoglossal nerve stimulator from Shanghai Shanling, a cataract treatment device from Zhejiang Boye, plus a medical electron linear accelerator from Beijing Huake Pioneer and an ultra‑high dose rate electron beam system from Zhongjiu Flash.

It is important to note that this notice is a preliminary review and does not constitute final admission into the special review process—only the official decision will be conclusive. Moreover, admission does not imply that the products have already demonstrated safety and efficacy for registration; applicants must continue full‑scale R&D and submit formal registration applications as required.

The regulatory authority will conduct evaluation under the principles of “early intervention, dedicated personnel, and science‑based review,” without lowering standards or cutting procedural steps. Any objections should be submitted in writing to gcdivision@cmde.org.cn during the comment period.