In the second half of March, the National Medical Products Administration (NMPA) released a flurry of updates on medical device approvals and regulatory developments.Four Innovative Medical Devices Approved for Marketing, While 14 Devices Voluntarily Recalled, covering key areas such as medical aesthetics, diagnostics, cardiovascular, and ophthalmology, with simultaneous progress in industry compliance and innovation.
1. Four Innovative Medical Devices Approved
From March 17 to March 31, a total of four medical devices were approved for marketing. The drug regulatory authorities have made it clear that they will continue to strengthen post-marketing supervision to ensure the safety of patients using medical devices.
| Implantable Ocular Muscle Neurostimulator
◆ Manufacturer:Super Vision Technology, Inc.
◆ Registration Certificate Number:China Medical Device Registration No. 20263120535
◆Core Information：The product, composed of a stimulator, receiving coil, electrode array, annular electrode, and internal magnet, is used in conjunction with a specific external power supply device to improve congenital horizontal nystagmus symptoms in patients aged 8 years and above.
It adopts implantable extraocular muscle neuromuscular stimulation technology, with minimal local trauma, strong controllability, and stable treatment effects, being a globally pioneering product.
◆Source of Information:
https://www.nmpa.gov.cn/zhuanti/cxylqx/cxylqxlm/20260317110208123.html
| CO2 Contrast Pressure Injection Set
◆ Manufacturer:Beijing Advanced Medical Technologies Co., Ltd.
◆ Registration Certificate Number:China Medical Device Registration No. 20263030556
◆Core Information：The product consists of a contrast injector, infusion tubing, and a double-lock filter. It is used for injecting carbon dioxide into the renal artery, iliac artery, lower limb arteries, forearm veins, inferior vena cava, and iliac veins for angiography. It is suitable for patients allergic to iodinated contrast agents, those with chronic kidney disease stages 3-5, and hyperthyroidism patients.
◆Source of Information:
https://www.nmpa.gov.cn/zhuanti/cxylqx/cxylqxlm/20260324172734189.html
| Transcatheter Mitral Valve Clip System
◆Manufacturer:Yingmai Medical Technology (Shanghai) Co., Ltd.
◆ Registration Certificate Number:China Medical Device Registration No. 20263130557
◆Core Information：The product consists of a mitral clip and catheter delivery system, and a steerable guiding catheter. It is delivered percutaneously and is suitable for patients with degenerative mitral regurgitation (MR≥3+) who are at high risk for surgical procedures and have appropriate mitral valve anatomy.
◆Source of Information:
https://www.nmpa.gov.cn/zhuanti/cxylqx/cxylqxlm/20260324173001114.html
Cryotherapy Device, Balloon-Type Cryoablation Catheter for Single Use
◆ Manufacturer:Sinopath Medical Technology (Beijing) Co., Ltd.
◆ Registration Certificate Number:Cryogenic Ablation System (China Medical Device Registration No. 20263010615), Single-Use Balloon Cryogenic Ablation Catheter (China Medical Device Registration No. 20263010616)
◆Core Information：The Cryoablation System, used in conjunction with a single-use balloon-type cryoablation catheter, is indicated for the treatment of adult patients with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation.
This product uses a compliant, adjustable-diameter balloon, a first in China, and is expected to improve the success rate of pulmonary vein occlusion.
◆ Source of Information:
https://www.nmpa.gov.cn/zhuanti/cxylqx/cxylqxlm/20260331093237152.html
2. Voluntary Recall of 14 Medical Devices
This recall involves companies such as Allergan, Siemens, Medtronic, and Smith & Nephew, all of which have fulfilled their obligations for voluntary recalls as required. Below is a brief table compiled based on official announcements:
▲ Source: Compiled by the author
◆Source of Information:
https://www.nmpa.gov.cn/xxgk/chpzhh/ylqxzhh/index.html
The above is for this issue.Medical DeviceLatest Summary of Approvals and Recalls. Innovation and Compliance in Tandem, Safety and Efficacy as Top Priorities. For more updates on the medical device industry, stay tuned.
