CMDE Releases 2026 14th Batch of Innovative Medical Device Special Review Public Notice

On August 25, 2026, the Center for Medical Device Evaluation of the National Medical Products Administration officially published the "Public Notice of Review Results for Innovative Medical Device Special Review Applications (2026 No. 14)," preliminarily approving 11 innovative medical device projects to enter the special review procedure. The public comment period runs from August 25 to September 8, 2026.

The announced projects span multiple cutting-edge technology areas, including:

l Cardiovascular: Aortic Root Patch (Beijing Balance Medical Technology), Aortic Valve Replacement System (Shenzhen Jianxin Medical Technology), Bioresorbable Left Atrial Appendage Occluder (Shanghai Shape Memory Alloy)

l Oncology Treatment: Single-use Pulsed Field Ablation Electrode Needle (Hunan E-video Medical Devices), Boron Neutron Capture Therapy System (Hua Boron Neutron Technology (Hangzhou))

l Ophthalmology: Artificial Corneal Endothelial Lamellar Graft (Ai Eye Medical)

l Brain-Computer Interface & Neuromodulation: Implantable Brain-Computer Interface Neurostimulator (Beijing Pins Medical), Implantable Tibial Nerve Stimulation System (Hangzhou Shenluo Medical Technology), Focused Ultrasound Neuromodulation Device (Chongqing Haifu Technology)

l Molecular Diagnostics: Human Circulating Tumor Molecular Residual Disease Detection Kit (Combined Probe Anchoring Polymerization Sequencing) (Guangzhou Burning Rock Medical Examination Institute)

l Biomaterials: Absorbable Spinal Dura Sealant Glue (Shandong Junxiu Biotechnology)

Important Notes:

l This public notice does not serve as the final basis for the aforementioned devices to enter the innovative device special review procedure; final determination will be made based on the review conclusion.

l Entry into the special review procedure does not indicate that the product has been deemed safe and effective for registration. Applicants are still required to conduct R&D and file registration applications in accordance with relevant requirements. The drug regulatory authorities and relevant technical institutions will conduct review and approval following the principles of "early intervention, dedicated personnel, and scientific review," without lowering standards or reducing procedures.

For any objections during the public comment period, please submit written opinions to: gcdivision@cmde.org.cn.