Australia Therapeutic Goods (Medical Devices) Regulations 2002 r10.2: Sponsor identification: provide the sponsor's name and address with the device so users can readily identify the sponsor, located as clause 13.2 requires, and never let an added label adulterate the device or obscure the manufacturer's information

What does r10.2 require?

The sponsor must make sure its name and address are supplied with each device so that a user can readily identify it, positioned in line with the clause 13.2 location rules (on the device, packaging, outer packaging, leaflet or electronically for software). If the sponsor adds a label for this or any other purpose (for instance a State or Territory labelling law), the label must not adulterate the device or obscure the manufacturer's information. Each breach carries 10 penalty units.