I would have thought that TGA registration is the major...

I would have thought that TGA registration is the major requirement for import and sale of these masks in Australia? They will need to secure CE and FDA approval first and that can take time.
What is the eta for delivery of the first orders? PlanarTech would have to hustle and hope FDA are streamlining PPE approvals so they can sell in the US. Unless they aren’t classified for medical use... I feel they would have it under control though... Won’t be too long before there is a reseller you can purchase the masks from if they prove as effective and popular as hoped.