(1)

The sponsor of a medical device imported into Australia must ensure that information about the sponsor is provided in such a way as to allow the sponsor to be identified.

(2)

If the sponsor of a medical device arranges for a label to be attached or affixed to the device for the purpose of complying with subregulation (1) or for any other purpose (for example, to comply with a labelling requirement under the law of a State or Territory), the label must not in any way adulterate the device or obscure the information provided with the device by the manufacturer.

Penalty:
10 penalty units.