More clarity and consistency on the necessary Covid-19 self-test kits

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SINGAPORE – The protocols on the Health Sciences Authority (HSA) Covid-19 self-test kits are puzzling me.

As of December 23, the HSA has allowed local and foreign travelers entering Singapore to bring up to 20 rapid antigen test (ART) kits which may not have been authorized for use here, provided they are approved for use by a regulatory body in another country.

The reason given is that it might be difficult for them to get the kits after they arrive, and they would need them almost immediately for their required daily testing.

The HSA said it decided to use 20 kits per person because “this number is based on the requirement for incoming travelers to self-test daily for 14 days, with the option of retesting.”

Very good, although I don’t see why ART kit dispensers that accept credit cards cannot be placed at the airport to facilitate purchase by inbound passengers. Likewise, kits could be sold at the pavement for those authorized to enter under the Vaccinated Travel Lane (VTL) land program with Malaysia.

What puzzles me is the HSA’s decision to ban the importation of kits approved by other regulators, other than the 11 kits it has approved for use in Singapore.

Regarding kits not on its list of 11, the HSA said: “As some of these test kits, the quality and effectiveness of which have not been evaluated, may be resold locally, the HSA had banned their imports to protect public health. “

He also warned that “any wholesale delivery of self-test kits is also not permitted and will require licensing and authorization from the HSA.”

On top of that, authorities are making it difficult for local manufacturers to get approval for ART kits made here to be sold here.

Kits require either prior approval from a recognized authority such as the United States Food and Drug Administration, or publication in an international journal on their effectiveness, before being invited by the Department of Health to submit them to HSA for approval.

These stringent requirements are normally only needed for equipment considered to be of higher risk, usually because it is intrusive – such as heart valves or implantable defibrillators – therefore, their approval requires greater approval. caution.

The fact that these regulations apply to ART kits reflects the importance of Covid-19 test results, hence high levels of safety and efficacy are required.

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