Keelung Customs (KLC) said: “The Food and Drug Administration (FDA) has loosened up the restriction on importation of oximeters. That is, by the end of 2021, each person living in Taiwan is allowed to carry from overseas or import one oximeter without a permit from the FDA.”
According to KLC, normally a prior FDA approval is a must for introducing a medical oximeter into Taiwan if it should be, based on its user information, regarded as a ”Medical Device ” as specifically defined by Medical Devices Act. However, the demand for this device has been considerably increased following quite a few sudden deaths of COVID-19 patients who were short of means to early detect their blood oxygen had dropped to fatal levels. In this context, the FDA relaxed current import restriction on oximeters during the period between June 28 and Dec 31 this year.
KLC further stressed that the above-mentioned contingency measure only applies to oximeters for personal use and each person is limited to one device. Furthermore, devices which cannot be operated without medical assistance shall still be subject to import licensing requirements.
Readers are welcome to visit https://www.fda.gov.tw for more information.