2024年10月30日，国家药品监督管理局公示显示，华为终端有限公司获批一款注册证编号为“国械注准 20263072228”的持续葡萄糖监测系统（CGM）1。这是华为首个三类医疗器械，标志着其从二类健康辅助监测进入临床级连续监测领域1。华为终端BG CEO何刚曾确认血糖检测设备研发已进行四年1。
三类医疗器械属于中国监管体系最高等级，与心脏支架、人工关节同级1。行业共识认为MARD≤10%为高精度，国家药监局要求检测结果与静脉血一致性达95%以上，误差控制在±15%以内1。此前华为在腕部动态血压记录仪等产品上持有二类证1。目前尚未公布产品名称、售价及具体上市时间1。
Huawei Terminal Co., Ltd. has officially received approval for its first Class III medical device, a continuous glucose monitoring (CGM) system, marking the company's entry into the clinical-grade continuous monitoring sector. 1 The National Medical Products Administration announced the clearance on October 30, 2024, assigning the registration certificate number "Guo Xie Zhu Zhun 20263072228" to the product. 1 This regulatory milestone signifies a shift from Huawei’s previous focus on Class II health auxiliary monitoring devices, such as wrist-worn dynamic blood pressure recorders, to higher-risk, clinically regulated equipment. 1
Class III designation represents the highest level of medical device regulation in China, placing the CGM system in the same regulatory tier as critical implants like cardiac stents and artificial joints. 1 To meet national standards, the device must demonstrate consistency with venous blood test results at or above 95%, with error margins controlled within ±15%. 1 While industry consensus considers a Mean Absolute Relative Difference (MARD) of 10% or less as indicative of high precision, specific performance metrics for Huawei’s new system have not yet been disclosed alongside details regarding product name, pricing, or launch date. 1 He Gang, CEO of Huawei’s Consumer Business Group, had previously confirmed that the development of the blood glucose detection equipment had been underway for four years. 1
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