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News & Trends - MedTech & Diagnostics

Legal supply of COVID-19 diagnostic tests

Health Industry Hub | March 25, 2020 |

MedTech News: To support efforts in managing the COVID-19 emergency, the Therapeutic Goods Administration (TGA) is working with suppliers to ensure that Australia has laboratory and point of care tests (POCT) available that are able to accurately detect COVID-19 infections.

There are two pathways to legally supply these types of tests.

  1. Undergoing an expedited TGA assessment of the COVID-19 test for inclusion on the Australian Register of Therapeutic Goods (ARTG). Once approved for inclusion on the ARTG, the COVID-19 test can be legally supplied in Australia.
  2. Supply of COVID-19 tests under the new Therapeutic Goods (Medical Devices Accredited Pathology Laboratories) (COVID-19 Emergency) Exemption 2020. This exemption permits importation, manufacture and supply of COVID-19 tests (that have not undergone TGA assessment) to accredited pathology laboratories.

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The TGA has now approved the following tests for inclusion on the Australian Register of Therapeutic Goods (ARTG).

Expedited TGA assessment of COVID-19 diagnostic tests

COVID-19 is an emerging viral infectious disease. There is limited information available regarding the disease profile and the ability of available tests to accurately detect COVID-19 infections.

The TGA is currently undertaking an expedited assessment process based on the information and performance data currently available at the time of application for inclusion on the ARTG. All COVID-19 tests that are included on the ARTG based on this expedited assessment process are subject to additional non-standard conditions, which makes it easier for the TGA to perform additional post market assessments as experience and knowledge around COVID-19 diagnostic testing grows.

The conditions require that additional evidence to support the ongoing safety and performance of the devices be provided to the TGA within 12 months of approval.

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Exemption for supply of COVID-19 tests to accredited pathology laboratories

A new emergency exemption, Therapeutic Goods (Medical Devices Accredited Pathology Laboratories) (COVID-19 Emergency) Exemption 2020, has been made to allow rapid supply of COVID-19 diagnostic tests to all Australian accredited pathology laboratories.

In practice this emergency exemption allows COVID-19 diagnostic tests to be immediately supplied to accredited pathology laboratories approved under the Health Insurance Act 1973, while the TGA continues to expedite the regulatory assessment process for these devices.

The exemption does not allow for general supply of rapid tests, including serological rapid tests intended for use at the point of care (POCT), other than to the accredited pathology laboratories specified in the exemption. Although, point of care tests (POCT) that have been included on the ARTG will be available for broader supply within Australia.


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