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The Therapeutic Goods Administration (TGA) has issued five infringement notices totalling $66,600 to 2San Pty Ltd for allegedly failing to provide information to the TGA to demonstrate the ongoing minimum level of sensitivity of two COVID-19 rapid antigen tests (RATs).
All sponsors of medical devices approved by the TGA are required by law to provide this evidence to the TGA when requested and within the specified timeframe. This helps ensure medical devices are safe and perform suitably for their intended purpose.
2San Pty Ltd has been issued multiple infringement notices for serial non-compliance in not meeting deadlines for providing information to the TGA. Officers of the TGA contacted the company on several occasions over a two month period to remind them of their obligations.
This compliance action serves as a reminder to companies to take their obligations seriously.
The TGA has published regulatory guidelines for importers, suppliers, and manufacturers of medical devices, as well as information on our post-market review of the ability of COVID-19 tests to detect emerging genetic variants of SARS-CoV-2.
Suppliers of products such as COVID-19 tests must meet their ongoing responsibilities with respect to post-market vigilance and monitoring. The TGA encourages potential suppliers to be aware of the requirements for supplying therapeutic goods in Australia.
If you suspect non-compliance, you can report illegal or questionable practices online to the TGA.
Contact for members of the media:
- Email: news@health.gov.au
- Phone: 02 6289 7400