The Apple Watch Series 6, which was unveiled on Tuesday in California, would not have the blood oxygen monitoring feature in those units sold in Taiwan, as such functions are restricted to medical equipment in the nation, the Food and Drug Administration (FDA) Director Wu Hsiu-mei (吳秀梅) said yesterday.
Many consumer electronics products feature health functions, which in Taiwan is under the sole domain of medical equipment, Wu said.
Such devices may only be sold with the FDA’s approval, she said.
Photo: EPA-EFE
As Apple has not tendered an application for the product, the function would be disabled in all Apple Watch Series 6 imported to Taiwan, she added.
People interested in buying an Apple Watch that has the feature from an online store abroad should instead buy FDA-approved equipment for monitoring their blood oxygen level, she added.
Separately, the FDA’s Web site announced that Apple’s electrocardiogram (ECG) application has been approved, after the app was initially blocked due to approval requirements for medical equipment.
FDA official Fu Ying-hsien (傅映先) said that the agency has approved Apple’s application for the ECG app featured on the Apple Watch Series 2, adding that the FDA is waiting for Apple’s Taiwan branch to pick up the license.
Additional reporting by Huang Ching-chun
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