Just like every other nation, Australia has also taken several measures to respond to the global pandemic. To help prevent shortages of medical equipment and personal protective equipment, the Australian regulating authority- Therapeutic Goods Administration (TGA) has announced several exemptions and expedited paths to ensure an adequate supply of medical products...

1. Australia’s Response to COVID-19
By: Nikita Angane, MS
Just like every other nation, Australia has also taken several measures to respond to the global
pandemic. To help prevent shortages of medical equipment and personal protective equipment,
the Australian regulating authority- Therapeutic Goods Administration (TGA) has announced
several exemptions and expedited paths to ensure an adequate supply of medical products. Below
are some exemptions and the expedited pathways that manufacturers are allowed to take in order
to ramp up their production when required.
On March 22nd, 2020, TGA released the Therapeutic Goods (Medical Devices—Accredited
Pathology Laboratories) (COVID-19 Emergency) Exemption 2020 that exempted all accredited
pathology laboratories from being listed on the Australian Register of Therapeutic Goods
(ARTG) for COVID-19 test kits.1
TGA also released another guidance document on March 22nd, Therapeutic Goods (Medical
Devices—Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020 that
outlines the temporary policy for face masks and ventilators. The policy exempts disposable face
masks, gloves, surgical gowns, and other PPEs from requirements such as listing in the
Australian Register of Therapeutic Goods (ARTG).1 The policy published on April 8,
Therapeutic Goods (Medical Devices—Ventilators) (COVID-19 Emergency) Exemption 2020
allows for Off-label use and modifications to the ventilators, anesthesia gas machines, and other
devices intended for respiratory support. Local ventilator manufacturers are allowed to distribute
their products provided that the devices meet the technical specifications outlined in ‘Ventilator
for COVID-19 use in Australia’2 and that the following conditions are met:3
 The manufacturer provides to the Therapeutic Goods Administration the test procedure,
test results and risk analysis undertaken concerning the specified kind of medical device
and a declaration that the specified kind of medical device has been manufactured
following the minimum technical requirements.
 Obtain written permission from the Therapeutic Goods Administration that, the medical
device may be legally distributed.
 Provide TGA with the information about any malfunction or deterioration in the
characteristics or performance of the medical device that might lead to a serious threat to
public health.
 Submit adverse event reports to the TGA within 48 hours of becoming aware of the
incident.

2. Page 2 of 2
We here at EMMA International are closely monitoring the changing regulatory landscape and
will keep you updated on how it may impact your product.
Have more questions? Call us today at 248-987-4497 or email us at
info@emmainternational.com.
1 Emergo (April 2020) TGA reacts to COVID-19 crisisin Australia retrieved on 04/23/2020 from
https://www.emergobyul.com/blog/2020/04/tga-reacts-covid-19-crisis-australia
2 AUS TGA (April 2020) Ventilator for COVID-19 usein Australia retrieved on 04/23/2020 from
https://www.tga.gov.au/sites/default/files/ventilator-covid-19-use-australia.pdf
3 AUS TGA (April 2020) Information for clinicianson ventilators and alternativestrategies when in short supply
duringCOVID-19 retrieved on 04/23/2020 from https://www.tga.gov.au/information-clinicians-ventilators-and-
alternative-strategies-when-short-supply-during-covid-19