Document ID: chunk:federal_register_of_legislation:C2007C00653:clause:1_41maa
Version: federal_register_of_legislation:C2007C00653
Segment Type: clause
Provision Reference: sch 1 cl 41MAA
Character Range: 86775–88207

41MAA  Civil penalties for importing, supplying or exporting a medical device that does not comply with essential principles

Civil penalty relating to importing a medical device

 (1) A person contravenes this subsection if:
 (a) the person imports a medical device into Australia; and
 (b) the medical device does not comply with the essential principles relating to matters other than the labelling of the device; and
 (c) the Secretary has not consented to the importation.

Maximum civil penalty:
 (a) for an individual—5,000 penalty units; and
 (b) for a body corporate—50,000 penalty units.

Civil penalty relating to supplying a medical device

 (2) A person contravenes this subsection if:
 (a) the person supplies a medical device for use in Australia; and
 (b) the medical device does not comply with the essential principles; and
 (c) the Secretary has not consented to the supply.

Maximum civil penalty:
 (a) for an individual—5,000 penalty units; and
 (b) for a body corporate—50,000 penalty units.

Civil penalty relating to exporting a medical device

 (3) A person contravenes this subsection if:
 (a) the person exports a medical device from Australia; and
 (b) the medical device does not comply with the essential principles; and
 (c) the Secretary has not consented to the exportation.

Maximum civil penalty:
 (a) for an individual—5,000 penalty units; and
 (b) for a body corporate—50,000 penalty units.