Sponsors gear up for a smoother process with CTIS but must first overcome key hurdles
Author: Ivy Cheng, Associate Director – Medical Devices / IVD
The supply of home tests for COVID-19 is currently prohibited in Australia however, following the recent announcement by the Federal Minister for Health and Aged Care, the Australian Therapeutic Goods Administration (TGA) will issue new regulations to allow sponsors to:
- apply for inclusion in the Australian Register of Therapeutic Goods (ARTG) after 1 October 2021 and
- legally supply individual COVID-19 rapid antigen self-tests for use at home in Australia, after 1 November 2021.
A review of supporting data and information has already commenced for sponsors that have registered their expression of interest in supplying COVID-19 rapid antigen self-tests for home use with the TGA.
In the review process, specific areas of focus will likely include suitability of:
- The manufacturer’s QMS certifications for the test;
- Risk Management plans to include ongoing monitoring of the Covid variants;
- Instructions for use that are written for all consumers to understand;
- Sponsors processes to provide support to end-users in performing the test and in meeting their regulatory obligations (e.g. Adverse event reports, advertising)
- Stability, analytical and clinical performance data, including evidence that the test performs satisfactorily against variants such as Delta;
Usability studies, that are representatives of untrained and unsupervised users.
In order to assist sponsors and manufacturers when preparing their technical documentation for submission, the TGA has provided guidance documents for performance requirements and risk mitigation strategies as well as software for use with COVID-19 rapid antigen self-test.
Navigating the ever-changing Regulations can be perplexing. Our team is here to support you in these challenging times. Reach out to initiate a conversation and see how we can support you.
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