The National Medical Products Administration of China has officially approved a continuous glucose monitoring (CGM) system developed by Huawei Device Co., Ltd. The product is registered under the certificate number 20263072228, as indicated in the regulatory filing dated October 30.
This approval classifies the device as a Class III medical device, the highest regulatory tier in China, placing it in the same category as heart stents and artificial joints. Previously, Huawei's health monitoring solutions, such as wrist-based blood pressure recorders and sleep apnea screening software, were limited to Class II certification.
The regulatory standards for this CGM require the device to maintain at least 95% consistency with venous blood glucose levels, with errors controlled within a range of plus or minus 15%. The industry standard for high-precision clinical decision support is defined by a Mean Absolute Relative Difference (MARD) value of 10% or less.
Huawei has been developing glucose monitoring technology for four years, a project confirmed by He Gang, CEO of Huawei Device BG, in September 2026. While the company previously offered high-blood-sugar risk assessments via the Watch 4 series, this new device marks its entry into clinical-grade monitoring.
Despite the regulatory approval, Huawei has not yet disclosed the official product name, retail pricing, or the specific market launch date. Further details regarding the commercial availability of the CGM system are expected to be announced by the company at a later time.
