24 April 2020
The TGA has issued infringement notices totalling $25,200 to Queensland company CK Surgitech for alleged breaches relating to COVID-19 test kits.
17 April 2020
The TGA has been involved in exploring ways to further increase supply of ventilators when and where they are needed
16 April 2020
During the COVID-19 pandemic, many businesses are encountering therapeutic goods regulations for the first time. This information explains the labelling requirements for medical devices to help manufacturers and sponsors meet their obligations.
7 April 2020
This new specification details the minimum technical requirements for manufactured invasive ventilators when approved devices are not available during the COVID-19 emergency.
2 April 2020
Information about the steps we are taking to make sure there are enough ventilators to match demand during the COVID-19 pandemic
31 March 2020
Clarification about the clinical trial process as it relates to COVID-19
27 March 2020
We have investigated a report that intravenous high-dose vitamin C may be beneficial in the management of COVID-19
24 March 2020
Certain medical devices for the diagnosis and treatment of COVID-19 will be exempt from various provisions of the therapeutic goods act to facilitate necessary access
24 March 2020
Only certain types of specialists will now be able to prescribe hydroxychloroquine to new patients
19 March 2020
Information for manufacturers of therapeutic goods about the suspension of all overseas GMP (Good Manufacturing Practice) inspections and QMS (Quality Management System) audits