In 2025 China’s regulator approved 76 home‑grown medical devices, marking the third straight year of record‑high innovation. From AI‑driven tumor radiotherapy tools to next‑generation biomaterials, Chinese firms are moving from import‑dependence to becoming the primary source of high‑end equipment in hospitals. Policy reforms at the National Medical Products Administration have streamlined approvals with special‑innovation pathways, early‑stage regulatory involvement and priority catalogs for brain‑computer interfaces, high‑resolution imaging and medical robots. The result: a faster route from R&D to bedside. Real‑world examples illustrate the shift. A domestic pulsed‑field ablation system now treats atrial fibrillation with fewer side effects than imported alternatives. GeneTech’s transcatheter aortic valve, OrthoMind’s micro‑robotic spine‑navigation arm, photon‑counting CT scanners from Neusoft and United Imaging, and Xi’an EyeD’s intra‑ocular lens all received clearance this year, breaking long‑standing import monopolies. Lower procurement costs—thanks to centralized buying and insurance negotiations—are bringing these once‑luxury devices into regional hospitals. Internationally, China now supplies about 8 % of the global medical‑device market, ranking fourth, and is aligning its standards with the IMDRF, paving the way for global expansion. The combined effect is better outcomes, higher quality, and more affordable care for patients at home and abroad.
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