45 Innovative Medical Devices Approved in 2026 — Record High Half-Year Performance Exceeds Full-Year 2025 Total, China’s Innovation Acceleration Milestone

China’s National Medical Products Administration (NMPA) has approved 45 innovative medical devices as of July 2, 2026 — already exceeding more than half of the entire 2025 annual total, establishing a new record for first-half-year performance. This milestone signals China’s accelerating pace of medical device innovation approval and the deepening impact of the NMPA’s innovative medical device special approval pathway.

Recently Approved Innovative Products

The NMPA recently approved several notable innovative products, including:

1.Xikainuo Medical — Intracranial Stent: A stent designed with closed-cell spiral line splicing design, closed-loop configuration, and full radiopaque design, intended for use with embolization devices in treating intracranial anterior circulation saccular wide-necked aneurysms. The design enables excellent flexibility and wall apposition, re-adjustable retrieval, and precise positioning.

2.Wushuang Medical — Implantable Cardiac Event Monitor (ICM): China’s first domestically developed implantable cardiac event monitor, filling a significant gap in China’s ICM market. The device records subcutaneous ECG for patients with clinical symptoms or transient symptoms at increased risk of or diagnosed with arrhythmia. This approval represents a breakthrough in China’s long-term cardiac monitoring capabilities.

3.Taijie Weiye — Intracsaccular Aneurysm Embolization System: Designed for small-to-medium saccular wide-necked intracranial bifurcation unruptured aneurysms (3-15mm diameter, neck ≥4mm). The device features a two-dimensional disc structure with recessed bottom design — the implant is entirely contained within the aneurysm sac without covering the parent artery, typically eliminating the need for permanent dual antiplatelet therapy and reducing associated bleeding risk.

4.Zhongke Rongguang Medical — Third-Harmonic Nd:YAG Laser Ablation Device: Using third-harmonic solid-state laser technology outputting 355nm wavelength laser energy through catheter delivery to lesion sites for lower extremity arterial stenosis/occlusion recanalization pretreatment. This is China’s first domestically developed 355nm UV laser vascular ablation device, improving debulking efficiency for occlusive lesions.

5.Hanling Medical — Transcatheter Aortic Valve System: A dedicated balloon-expandable valve solution for aortic valve insufficiency (severe aortic regurgitation) patients aged ≥70 who are ineligible for conventional surgical valve replacement. The system integrates sinus-bottom anchoring, valve leaflet clamping, and adjustable-curve precision delivery, expected to improve implantation success rates and reduce valve migration, paravalvular leak, and permanent pacemaker implantation risks.

Policy Context: Innovative Device Special Approval Pathway

China’s innovative medical device special approval pathway, established in 2014, provides expedited review for products meeting criteria including: - First-in-class domestically or globally - Significant clinical value - Fundamental technological innovation

The pathway offers priority review, early communication with NMPA reviewers, and accelerated timeline from application to approval. The cumulative total of innovative medical device approvals since the program’s inception has reached 434 products as of mid-2026, reflecting the sustained growth of China’s medical device innovation ecosystem.