Since March, the National Medical Products Administration has issued several announcements in the medical device industry. On one hand, two major innovative devices have been approved for marketing, coveringCardio-cerebral vascular intervention, Brain-computer interfaceTwo cutting-edge fields, achieving breakthroughs in core technologies;
On the other hand, according to the enterprise application,Cancellation of 9 Medical Device Registration Certificates from 4 Enterprises, involving multiple categories such as spinal fixation devices and hemodialyzers, with industry regulation becoming increasingly standardized.
/01/
Two Major Innovative Medical Devices Approved for Marketing
| Biodegradable PFO Occluder System Approved for Marketing
◆ Manufacturer:WYTD MEDICAL TECHNOLOGY (SHENZHEN) CO., LTD.
◆Registration Certificate Number:CN Medical Device Registration No. 20263130458
◆Core Information：The product consists of an occluder, a delivery and cutting device, a loader, etc. The occluder adopts a design of PDO degradable wire weaving + PLCL degradable blocking membrane. Meanwhile, the occluder is divided into two models, A and B, with model A having tantalum radiopaque marker rings while model B does not.
This system is suitable for patients aged 18-60 with a history of unexplained stroke, where there may be a causal relationship between patent foramen ovale (PFO) and ischemic stroke, and the PFO has high-risk anatomical features. Closure treatment can be performed after joint decision-making by neurologists and cardiologists.
◆Source of Information:
https://www.nmpa.gov.cn/zhuanti/cxylqx/cxylqxlm/20260312084044174.html
| First Invasive Brain-Computer Interface Medical Device Approved for Marketing
◆ Manufacturer:Neuracle Technology (Shanghai) Co., Ltd.
◆ Registration Certificate Number:Implantable EEG Electrode Kit (China Medical Device Registration No. 20263120536), Implantable Brain-Computer Interface Hand Motor Function Compensation System (China Medical Device Registration No. 20263120537)
◆Core Information：The product consists of a brain-computer interface implant, an implantable EEG electrode kit, a pneumatic glove device, related software, etc., utilizing epidural minimally invasive implantation and wireless power supply communication technology. It is the world's first approved invasive brain-computer interface medical device.
It is suitable for quadriplegic patients aged 18-60 with C2-C6 cervical spinal cord injury graded A-C, who retain partial upper arm function. Additionally, the patient must have been diagnosed for over a year and have had a stable condition for more than six months following standardized treatment. This device can assist in achieving hand grip function compensation, and clinical trials have confirmed it significantly improves patients' quality of life.
◆Source of Information:
https://www.nmpa.gov.cn/zhuanti/cxylqx/cxylqxlm/20260313134742156.html
/02/
Nine Medical Device Registration Certificates Revoked
On March 10, 2026, the National Medical Products Administration (NMPA) announced that, based on corporate applications and provisions of the Regulations on the Supervision and Administration of Medical Devices, the medical device registration certificates for nine products from four companies were canceled. The specific information is shown in the table below:
▲ Source: Compiled by the author
◆Source of Information:
https://www.nmpa.gov.cn/xxgk/ggtg/ylqxggtg/ylqxqtggtg/20260310165205183.html
The industry updates released this time not only demonstrate China's R&D strength and breakthroughs in the field of high-end innovative medical devices, but also the market launch of the first invasive brain-computer interface medical device has achieved international leadership.
At the same time, the常态化 cancellation of medical device registration certificates also reflects the strictness and standardization of industry regulation, promotingMedical DeviceThe industry achieves survival of the fittest and high-quality development.
