Australia’s TGA Issues New Guidance on Clinical Evidence

Final guidance from Australia’s Therapeutic Goods Administration covers clinical evidence requirements for medical devices and in vitro diagnostics, including how the evidence should be obtained and what it needs to show.

Evidence must include clinical data from investigations, literature reviews, or post-market studies, and must ensure the data are evaluated by competent experts in the relevant fields, according to the TGA.

The guidance was developed to align with guidance published by the International Medical Device Regulators Forum and the European Commission.