China's First Domestically Developed ICD Approved by NMPA

On July 14, 2026, the National Medical Products Administration (NMPA) approved the registration of an implantable cardioverter-defibrillator (ICD) independently developed by Suzhou Wushuang Medical Device Co., Ltd. This is the first domestically produced ICD in China, filling a critical gap in the country’s cardiac device sector.

The device consists of an implantable pulse generator and a torque wrench. It provides ventricular antitachycardia pacing and defibrillation functions for patients with life-threatening ventricular arrhythmias. The system continuously monitors the patient’s heart rhythm and automatically identifies ventricular tachycardia or ventricular fibrillation. When the detected arrhythmia frequency exceeds the preset threshold, it delivers antitachycardia pacing or defibrillation shocks. The product incorporates an advanced ventricular tachycardia diagnostic algorithm and a low‑power circuit design, which help extend device longevity while ensuring therapeutic efficacy.

This ICD approval represents another significant achievement under the NMPA’s innovative medical device special review program. According to the official catalogue of approved innovative medical devices (2014–2026), a cumulative total of 438 innovative devices have been approved across China as of early July 2026, with 45 new products added in 2026 alone. Other noteworthy recent approvals include Suzhou Wushuang’s implantable cardiac monitor, Synergy Medical’s intracranial stent, an aneurysm intrasaccular embolization system, and a triple‑frequency Nd:YAG laser ablation device.

The NMPA has stated that it will strengthen post‑market surveillance of these products to ensure patient safety.