Commonwealth Consolidated Regulations

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THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002 - REG 10.2

Information about sponsor

  (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.

Penalty:   10 penalty units.

  (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.


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