New Product Launch
Notable Market Approvals of Domestic MedTech Innovations by China’s National Medical Products Administration (NMPA) Mainly Focusing on Those Approved through Fast Track Channel
The NMPA’s Fast Track Approval Channel expedites the review of innovative medical devices in China. This accelerated process applies to products that are domestic firsts, have core patented technology, and offer significant clinical value, particularly those addressing urgent clinical needs or major diseases in China. The channel uses methods like early intervention and dedicated case management to shorten the time to market, with an average reduction of 135 days.
Recent Launched Products
- NMPA Approves Domestic First Bio-Degradable Nasal Septal Cartilage Fixation SystemOn May 18, NMPA officially announced the marketing approval for the innovative “Nasal Septal Absorbable Fastener Fixation Device,” independently developed by Hefei Qihao Medical Technology Co., Ltd (Breath Medical). The product marks China’s first domestically approved fully degradable nasal septal cartilage fixation system. 1. Product Composition and Scope of Application… Read more: NMPA Approves Domestic First Bio-Degradable Nasal Septal Cartilage Fixation System
- Fishhawk® Disposable Thrombectomy Device Cleared for Deep Vein Thrombosis Is Approved by NMPAOn April 30, the Fishhawk® Disposable Thrombectomy Device of MicroPort Endovascular was approved by NMPA for commercialisation in China. Previously granted entry into the NMPA’s Green Channel for Innovative Medical Devices in 2022, this product is indicated for the percutaneous endovascular removal of acute iliac and deep femoral vein thrombosis.… Read more: Fishhawk® Disposable Thrombectomy Device Cleared for Deep Vein Thrombosis Is Approved by NMPA
- NMPA Approves Domestic Intracardiac Echocardiography (ICE) System, Advancing Precision Cardiac InterventionOn April 30, 2026, the Intracardiac Echocardiography (ICE) System and Disposable ICE Catheter—developed by Xi’an Huafeng Medical Technology Co., Ltd.—officially received market approval from the NMPA. Product Composition and Scope of Application The system comprises two core components working in tandem: the ICE Diagnostic Equipment (consisting of the main console,… Read more: NMPA Approves Domestic Intracardiac Echocardiography (ICE) System, Advancing Precision Cardiac Intervention
- Precision Repair for High-Risk Patients: The NovoClasp Transcatheter Mitral Valve Clip System from Enlight Medical Is Approved by NMPAThe NovoClasp Transcatheter Mitral Valve Clip System is a breakthrough device that offers a life-changing, minimally invasive alternative for patients suffering from severe degenerative mitral regurgitation (MR ≥3+) who are considered high-risk for open-heart surgery. Sophisticated Engineering for Complex Anatomy NovoClasp is designed for “edge-to-edge” repair, delivered via a percutaneous… Read more: Precision Repair for High-Risk Patients: The NovoClasp Transcatheter Mitral Valve Clip System from Enlight Medical Is Approved by NMPA
- ConBrella® Biodegradable PFO Occluder Approved by NMPAConBrella® Biodegradable Patent Foramen Ovale (PFO) Occluder System manufactured by Wuyou Tiaodong (WYTD) Medical Technology (Shenzhen) Co., Ltd. is officially approved by NMPA to launch in China. As the first PFO closure product in China to be approved through the “Green Channel,” ConBrella® marks a paradigm shift in structural heart… Read more: ConBrella® Biodegradable PFO Occluder Approved by NMPA
- Filling the Gap for High-Risk Patients: PIONEER TAVR® Transcatheter Aortic Valve System Approved by NMPAProduct Overview This innovative system from KOKA Lifesciences focuses on the precise clinical needs of elderly, high-risk patients suffering from symptomatic, severe aortic valve insufficiency (severe aortic regurgitation). It serves as a vital micro-invasive alternative for patients aged 70 and older who are deemed unsuitable for conventional open-heart surgical valve… Read more: Filling the Gap for High-Risk Patients: PIONEER TAVR® Transcatheter Aortic Valve System Approved by NMPA
