Huawei’s Continuous Glucose Monitor Clears China’s Toughest Device Tier

October 31 — Among the medical device approval documents published by China’s National Medical Products Administration on 30 October was one from “Huawei Device Co Ltd” for a product called “Continuous Glucose Monitoring System”, approved under national device registration number 20263072228.

Class III medical devices are the highest tier in China’s regulatory system, on a par with heart stents and artificial joints. Huawei’s previous health-monitoring approvals were Class II: wrist-worn ambulatory blood pressure recorders, sleep apnoea screening software, and pulse-wave atrial fibrillation and premature-beat alerts. Class III approval for a CGM means Huawei has moved from “health monitoring” into “clinical-grade continuous monitoring”.

The core value of a CGM is not a single glucose reading but the continuous trend of glucose in interstitial fluid. Compliant CGM products typically use MARD (mean absolute relative difference) to measure accuracy; the industry consensus is that MARD ≤10% counts as high accuracy, suitable for supporting clinical decisions.

MARD is the mean absolute relative error between CGM readings and venous blood reference values — the lower the number, the smaller the deviation. Chinese regulators require CGM results to agree with venous blood at over 95%, with error within ±15%.

The product did not appear from nowhere. He Gang, CEO of Huawei’s device business, confirmed in September 2026 that glucose-sensing hardware had been in development for four years, aiming for an “acceptable, manufacturable” solution. Yu Chengdong also teased that an independent blood-glucose medical device would launch within the year, without specifying whether it would be a CGM patch or another form.

Earlier, in 2023, the Huawei Watch 4 series already estimated high blood sugar risk from pulse waves, vascular elasticity and sleep data, but it only output a probability trend, not a specific glucose value. As of now, Huawei has not announced the product’s name, price or launch date.