Ann: Update to TGA Submission, page-147

medical devices are subject to mandatory audit and thus require batch testing even before being added to the ARTG. That is stated in the legislation.

They definitely do not just allow all products on the register without testing the scale aspect for a product intended for mass public screening. Batch/lot testing is a given.

They don’t just implement batch/or testing after the fact. PIQ obviously know that and have created enough kits from different batch numbers accordingly - a week after their TGA submission.

RHY had a bunch of prototypes/ manufactured a small amount. It’d be absolutely negligent for the TGA to approve their device intended for mass screening of populations without the batch testing using a handful of test kits.

A CR will come to fund the commercial batches required I’m thinking.