• Vikcess Business Group

Apple Watch Receives First Chinese Medical Device Registration Certificate

Updated: Jul 5, 2021

On June 26, Apple Watch received medical device approval from the National Medical Products Administration (NMPA). (Apple Inc.'s mobile ECG atrial fibrillation alerting software (registration certificate No. 20212210223))

According to the previous introduction of the ECG function in the Apple Health App, if the service is enabled, you can do an ECG on the Apple Watch. " ECG" App uses the Digital Crown of the Apple Watch to record the heartbeat, and then the App will check whether there is atrial fibrillation, a form of arrhythmia. The electrocardiogram ( ECG or EKG ) detection function allows users to know their heart condition at any time and anywhere, which can prevent some unexpected situations from happening.

The Global smart wearable devices market is booming

With the advancement of medical device technology, the increasing number of smartphone healthcare apps compatible with wearable devices, the growing preference of healthcare service providers for wireless connectivity, and the increasing importance the public places on physical health, the wearable medical device industry has seen explosive growth. In 2016, the global wearable medical device market had total sales of USD 2 billion, in 2017 it was USD 2,4 billion, in 2018 it was over USD 3 billion, and in 2023 it is expected to exceed USD 6 billion.

China's wearable medical device market is developing rapidly

In recent years, China's wearable medical device market has shown rapid development. IDC Data show that the market size of China's wearable medical devices reached 1.2 billion yuan in 2015, and the shipment of China's wearable devices market will be close to 110 million units in 2020, with a year-on-year growth of 7.5%. From the overall wearable device market, smart watch is one of the major players. Now with the NMPA approved ECG app, Apple Watch will accelerate the penetration of the Chinese market.

Apple has been deploying medical equipment for a long time

With the continuous hot sale of the iPhone and the continuous maturity of watchOS, Apple Watch gradually becomes the new dominant player in the smartwatch field at an amazing speed. According to the data published by IDC, Apple accounts for 40% of the global smartwatch market in 2020. As Apple CEO Tim Cook said referring to the potential, Healthcare makes the smartphone market look small.