(1) The sponsor of a medical device must ensure that the sponsor's name and address are:
(a) provided with the device in such a way that a user of the device can readily identify the sponsor; and
(b) located in accordance with clause 13.2 in Schedule 1.
(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.