The Food and Drug Administration (FDA) yesterday said it is investigating the online sale of rapid COVID-19 testing products in contravention of rules against the unlicensed sale of medical equipment and “distance” commerce.
Testing kits are classified as medical equipment and therefore can only be sold by certified vendors and pharmacies, FDA Medical Devices and Cosmetics Division specialist Lin Hsin-hui (林欣慧) said.
At present, there are no permitted “distance” channels to buy medical equipment, such as through the Internet, telemarketing, Line, Instagram or other social media platforms, Lin added.
Photo: Ritchie B. Tongo / EPA-EFE
Online influencers and retailers are not certified vendors, she said, adding that perpetrators could be consecutively fined NT$30,000 to NT$1 million (US$1,073 to US$35,778) in accordance with the Medical Devices Act (醫療器材管理法).
For example, an unlicensed vendor who is fined the maximum NT$1 million could be fined another NT$1 million for contraventions of distance sale regulations, Lin said.
The FDA is still gathering evidence and has not yet issued any fines, she said, urging the public to contact the agency or local health bureaus with any relevant information.
Photo: Fang Pin-chao, Taipei Times
While buying rapid testing kits from licensed vendors is not illegal, Lin advised against businesses purchasing them to test their employees, as the safety and accuracy of self-administered tests cannot be guaranteed.
Meanwhile, Vice President William Lai (賴清德) urged people who do not have any reason to suspect they might have contracted COVID-19 to stay away from rapid testing stations, as it could increase their risk of infection.
“In this battle, only the virus is the enemy,” Lai said on Facebook yesterday, before detailing current measures to fight the outbreak.
The rapid antigen test used to screen for COVID-19 does not test for the virus directly, resulting in some false positives and false negatives, and potentially either causing panic or missing cases, he said.
Rapid testing can therefore be used to screen hotspot areas, but more accurate nucleic acid testing must be used to formally diagnose cases to more accurately reflect trends, Lai said, calling on those without symptoms or a history of contact with COVID-19 cases to refrain from getting tested.
To relieve pressure on medical institutions, more screening stations and quarantine facilities are being set up nationwide, while thousands of physicians have responded to the call for help, he added.
Lastly, he thanked everyone for staying home over the past few days, leaving the usually bustling streets empty.
“These are not scenes of desolation, but demonstrate the people’s determination to resist the pandemic,” he said. “Thank you for staying home and working with the government to put a stop to the spread of this virus.”
As the incubation period of the UK variant is five to seven days, the effects of recent measures would begin to be apparent after this week, he said.
“There is no need for excessive worry,” he said. “As long as we continue wearing masks, practicing good hand hygiene, and avoiding unnecessary movement and gatherings, we can get through this and return to normal.”
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