Which Rats Are TGA Approved?
WouterWhen it comes to rat testing, the TGA has strict requirements and is able to take action to make sure the rat is safe and effective. If a rat fails to perform as promised, the TGA can suspend the product’s sale in Australia or cancel the license. They may also take action to review the testing devices and labelling of the product.
The TGA is the regulator in Australia for medical products. It has issued a warning against the use of unapproved RATs. The agency has also expressed concern about repackaged and relabelled rat products. Furthermore, it is concerned about people being treated with RATs who are COVID-19 positive.
There are currently only two companies in Australia manufacturing RATs: Innovation Scientific and Lumos Diagnostics. Although there are some overseas companies developing RATs for Australian use, they are still awaiting local approval. The Victorian government, for example, has signed a deal with Lumos Diagnostics to build a RAT manufacturing plant in the state. This deal is contingent on Lumos Diagnostics receiving TGA approval for its CoviDx test.
The TGA has received a report alleging that the company used fake documentation for their rapid antigen tests. The TGA has not yet responded to Guardian Australia’s request for comment. In the meantime, the TGA is investigating the allegations of using false documentation to sell rat testing kits in Australia.
