On October 8, China's Guangdong Provincial Food and Drug Administration issued the "List of Products Approved for the Pilot Approval of the Medical Device Registrant System in Guangdong Province (as of October 8, 2021)", and Huawei's wrist single-lead ECG collector was officially approved for production. In fact, in August this year, Huawei's multiple medical device products have entered the priority approval process.
According to the Guangdong Provincial Food and Drug Administration issued the "Guangdong Province Class II Medical Device Priority Approval Application Review Results Announcement (Issue 49)", Huawei’s wrist ECG blood pressure recorder, ECG analysis system, and arrhythmia analysis system 4 medical device products including wrist single-lead ECG collectors have officially entered the priority approval process. The four Huawei medical devices are all related to wrist ECG monitoring, and they are all wearable medical devices. Although Huawei has launched smart bracelet wearable devices as early as 2014, this time it is a large-scale deployment of medical-grade wearable devices.