Apple added the new ECG feature on the Apple Watch Series 4.  This feature has not been activated in Taiwan due to regulatory restrictions.  However, as the Medical Device Management Act passed the legislation in December 2019, will this feature finally be available in Taiwan?

The Pharmaceutical Affairs Act used to regulate the issues concerning drugs and medical devices despite the fact that these two product categories require very different regulations.  As technology advances and smart wearable devices become popular, the current regulations need to be updated to keep up with the developments.

In order to modernize the regulations, the MOHW, since 2014, has been working on the establishment of a set of separate regulations for medical devices.  The draft was completed in 2015 and finally passed the third reading in the Legislative Yuan in 2019.

The Act includes 85 articles, which emphasize on the post-marketing surveillance and clinical trial regulations, as well as encourage innovations. According to the Act, medical devices are classified into 17 categories at 3 risk classes.  For example, the ECG management systems are classified as Class 1 (i.e. low risk) cardiovascular medical devices, while cardiac monitors (including cardiometers and heart rate alarms) and arrhythmia detectors are classified as Class 2 (medium risk) medical devices.  Whether Apple Watch’s ECG feature can really benefit from the new regulations and, hence, be exempt from the TFDA’s long review process are not yet sure.

However, from the TFDA’s website, the new Medical Device Management Act still provides the industry with a lot of new hopes and opportunities. 

【2019-12-30 /  Tech News】