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Taiwan FDA allows in medical oximeters for individual use

2021-06-29
Focus Taiwan
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An oximeter. Pixabay image
An oximeter. Pixabay image

Taipei, June 28 (CNA) Taiwanese nationals will be allowed to bring in or mail from abroad a medical oximeter for personal use, the Taiwan Food and Drug Administration (FDA) announced Monday, in response to strong demand for the device.

The rule change is effective immediately through Dec. 31, amid high demand following multiple sudden deaths of COVID-19 patients due to "happy hypoxia," condition where an individual's blood oxygen level is dangerously low but those affected are oblivious to the danger.

According to medical experts, failure to regularly monitor oxygen saturation levels can result in organs shutting down and the condition can become life threatening without visible external signs in COVID-19 patients.

The FDA made the decision to permit "one oximeter per person" to assuage public complaints that medical oximeters they brought or mailed from overseas were confiscated by customs officials.

However, if a package contains two or more medical oximeters, the person must in advance seek an FDA approval which requires a certificate of diagnosis and the devices cannot be transferred or sold, FDA Medical Devices and Cosmetics Division specialist Lin Hsin-hui (林欣慧) told CNA.

If the device is to be used for sports related purposes, it does not have to be declared at customs, she added.

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