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

• Precision Repair for High-Risk Patients: The NovoClasp Transcatheter Mitral Valve Clip System from Enlight Medical Is Approved by NMPAMay 1, 2026
  The 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 NMPAMay 1, 2026
  ConBrella® 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 NMPAMarch 11, 2026
  Product 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
• Breakthrough in Precision Cardiac Access: RF-cross® Radiofrequency Transseptal NeedleMarch 11, 2026
  Product Overview The RF-cross® is China’s first transseptal puncture system to integrate “Zero-Exchange” workflow, mechanical + radiofrequency (RF) dual technology, and steerable sheath compatibility. It is designed to create a critical pathway from the right atrium to the left atrium via a transfemoral venous approach for various cardiac interventions. Key… Read more: Breakthrough in Precision Cardiac Access: RF-cross® Radiofrequency Transseptal Needle
• Approval of the EasyEcho™ Intracardiac Echocardiography Imaging CatheterFebruary 1, 2026
  On January 29, the National Medical Products Administration (NMPA) granted marketing approval to Shanghai MicroPort EP MedTech Co., Ltd. for the EasyEcho™ disposable intracardiac echocardiography (ICE) imaging catheter. This device is the first domestically produced ICE catheter to integrate magnetic positioning and ultrasound modeling within a small-diameter framework. Technical Specifications… Read more: Approval of the EasyEcho™ Intracardiac Echocardiography Imaging Catheter
• SceneRay Receives NMPA Approval for World-First DBS System Targeting Opioid AddictionJanuary 2, 2026
  In a landmark development for the global neuromodulation market, the National Medical Products Administration (NMPA) has officially granted marketing approval to SceneRay Medical’s Implantable Deep Brain Stimulation (DBS) System. This authorization marks a transformative shift in psychiatric care, signalling the arrival of the world’s first invasive brain-computer interface (BCI) specifically… Read more: SceneRay Receives NMPA Approval for World-First DBS System Targeting Opioid Addiction