TGA provides guidance on COVID-19 diagnostic tests

MedTech News: To ensure that the COVID-19 health response is well informed, the Therapeutic Goods Administration (TGA) is working with IVD suppliers to ensure that the tests used in managing this pandemic are able to accurately detect COVID-19 infections.

Exemption allows for immediate supply of COVID-19 tests

The Australian regulatory framework for medical devices allows National Association of Testing Authorities (NATA) accredited laboratories to develop and use their own laboratory developed tests without requiring those tests to be included in the Australian Register for Therapeutic Goods (ARTG). This has enabled Australian laboratories to immediately develop COVID-19 tests based on internationally available COVID-19 genomic information and to commence testing.

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To support a rapid COVID-19 response, tests used to test for COVID-19 will be exempt from particular requirements of the Therapeutic Goods Act 1989. This emergency exemption allows commercial suppliers of COVID-19 tests to immediately supply their tests to laboratories within the Australian Public Health Laboratory Network (PHLN). Because the PHLN is well integrated in state and territory public health systems, this will help facilitate reporting, recording and tracing of the spread of COVID-19 infections.

The TGA exemption does not allow for general supply of rapid tests, including serological rapid tests intended for use at the point of care, other than to the laboratories specified in the exemption.

COVID-19 IVD classification

The classification rules for IVDs are provided in Schedule 2A of the Therapeutic Goods (Medical Devices) Regulations 2002. Currently the TGA is processing COVID-19/SARS-CoV-2 assays as Class 3 IVDs.

In-house IVDs

In-house IVDs used for COVID-19 testing (i.e. assays that are developed and validated within a laboratory, rather than supplied by a commercial manufacturer) can be developed by laboratories under the NATA/National Pathology Accreditation Advisory Council (NPAAC) arrangements.

Such in-house assays will need to be notified to the TGA under the in-house IVD regulatory scheme, but they do not require inclusion on the ARTG. Both PHLN and non-PHLN laboratories can legally develop and use in-house COVID-19 assays under the current regulatory requirements, and there is no need for an exemption in relation to these in-house IVDs.

IVDs that are identified by the manufacturer as being intended for Research Use Only (RUO) are not regulated by the TGA. However, laboratories are able to validate such RUO products for use as in-house IVDs.

COVID-19 self-tests

In Australia, the supply of self-tests for most serious infectious diseases, including self-tests for COVID-19, is prohibited under the Therapeutic Goods (Excluded Purposes) Specification 2010.

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