Apple Watch mobile ECG and atrial fibrillation reminder functions are reviewed by China Food and Drug Administration

On June 26, Apple Watch was approved by the National Medical Products Administration for medical devices, and the mobile electrocardiogram (ECG) and atrial fibrillation reminder software passed the review.


In fact, Apple introduced the ECG electrocardiogram detection function on the Apple Watch Series 4 launched in 2018. However, because this function is a medical device attribute, Apple failed to pass the medical device certification of the Food and Drug Administration. The 4th generation watch was released. Initially, this function is not supported in China, which is what we often call “lock zone”.

The ECG electrocardiogram detection function allows users to know their heart conditions anytime and anywhere, and can avoid some accidents.

Until June 25, 2021, the “Medical Device Approval Document (Import) Pending Information” document issued by the National Medical Products Administration, the mobile electrocardiogram atrial fibrillation reminder software of Apple Inc. (Registration Certificate No.: National Instruments Note) Enter 20212210223) to be registered before the review is completed. Apple Watch users may be able to get this feature in the update soon.