The Therapeutic Goods Administration (TGA) has issued eight (8) infringement notices totalling $106,560 to Hough Pharma Pty Ltd for allegedly failing to provide information to the TGA to demonstrate the safety and performance of three COVID-19 rapid antigen tests (RATs).
All sponsors of medical devices approved by the TGA are required under the Therapeutic Goods Act 1989 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. Sponsors of self-test RATs must also ensure that telephone helpline or on-line operators are available to provide customer support services from 9am to 7pm (AEST), 7 days per week. This support is vital for consumers who purchase these tests who may have questions about the test, how it is performed or interpretation of results.
Hough Pharma Pty Ltd has been issued multiple infringement notices for serial non-compliance. In addition to not meeting deadlines for providing information to the TGA, the lack of customer support has been reported by consumers and verified by TGA investigations. The TGA is investigating other sponsors of COVID-19 rapid antigen tests for similar non-compliance.
This compliance action serves as a reminder to companies to take their obligations seriously.
Suppliers of therapeutic goods must meet their ongoing post-market safety, performance vigilance, and monitoring commitments.
The TGA has published for importers, suppliers, and manufacturers of medical devices, as well as information on our post-market review of .
Suppliers of products such as COVID-19 tests must meet their ongoing responsibilities with respect to . The TGA encourages potential suppliers to be aware of the requirements for .
If you suspect non-compliance, you can online to the TGA.
