Australia’s Therapeutic Goods Administration released guidance on its website to help sponsors through the process of registering Class IV in vitro diagnostics in the Australian Register of Therapeutic Goods.
Sponsors need to first submit manufacturer evidence, and the TGA needs to approve it before applications can be submitted.
The agency accepts the following certificates as manufacturer’s evidence:
The module walks sponsors through the process for working with the agency’s business services using the on-line portal to submit an application.
Sponsors will need to submit an evidence number, unique device identifiers and other supporting information.
Read the TGA guidance here: www.fdanews.com/09-15-16-TGAguidance.pdf. — Tamra Sami