Government filings suggest Apple ready to launch Apple Watch ECG feature in Brazil and Japan
As Apple continues to build out global support for ECG capabilities offered on Apple Watch Series 4 and Series 5 devices, recent government filings show Brazil and Japan could be next on the launch list.
In June, Japan's Pharmaceuticals and Medical Devices Agency (PMDA) updated its list of registered foreign manufacturers to add Apple as a certified entity, Mac Otakara reports. Companies on the list are evaluated based on contingencies stipulated in a legal act concerning the quality, effectiveness and safety of pharmaceuticals and medical devices.
While the nature of Apple's certification is not detailed in the PMDA publication, it is thought to be related to Apple Watch's ECG feature. In many countries, Apple must win approval from government health entities before marketing the ECG capability, and in some cases heart rate monitoring software, to consumers.
Prior to the Japan development, Brazil's Health Regulatory Agency, known by the acronym ANVISA, in May announced passage of a new resolution approving Apple Watch's irregular heart rate notification and ECG features for use by consumers.
Resolution No. 1.635 notes Apple's heart monitoring software was evaluated solely for its ability to detect atrial fibrillation, adding the accompanying ECG feature should be used only as an informational asset. As noted by both ANVISA and Apple, the hardware and software tool is not designed to detect heart attacks and does not diagnose heart disease.
Similar consumer warnings and device limitations came part and parcel with U.S. FDA clearance when Apple Watch launched in 2018.
9to5Mac reported on the Brazil's grant earlier today.
Health agency authorizations typically serve as a final step toward regional Apple Watch ECG availability, though they rarely offer insight into launch timing. After obtaining clearance from the appropriate body or bodies, Apple is able to activate the feature in a watchOS software update at its leisure.
Most recently, Saudi Arabia gained access to ECG data and irregular heart rhythm notifications with watchOS 6.2.5 in May.