NMPA Announces 2026 No. 18 Priority Approval Results for Medical Devices

On August 28, 2026, the Center for Medical Device Evaluation of the National Medical Products Administration released the "Public Notice of Priority Review Application Results for Medical Devices (2026 No. 18)".

In accordance with the Medical Device Priority Review Procedure, the Priority Review Medical Device Review Office will publicize projects that have been verified to meet the priority review criteria. The public comment period runs from August 28 to September 4, 2026.

The priority review project announced in this notice is as follows:

Acceptance No.: CQZ2601445

Product Name: Single-use Membrane Oxygenator Kit

Applicant: Aerospace XinChangzheng Medical Devices (Beijing) Co., Ltd.

Approval Reason: This product is included in the "2025 Catalog of High-End Medical Devices Eligible for Priority Review".

The membrane oxygenator is a core consumable for ECMO (Extracorporeal Membrane Oxygenation) systems. Its inclusion in the priority review pathway reflects the country's continued support for the domestic production of high-end medical devices. The "2025 Catalog of High-End Medical Devices Eligible for Priority Review," published on December 26, 2025, includes eight categories of high-end medical devices, such as Boron Neutron Capture Therapy (BNCT) systems, ultra-high field MRI equipment, and implantable Brain-Computer Interface (BCI) devices.

During the public comment period, any organization or individual with objections may complete the Medical Device Priority Review Project Objection Form and submit it to the CMDE email address: gcdivision@cmde.org.cn.