Document ID: chunk:federal_register_of_legislation:C2007C00653:clause:1_41mea
Version: federal_register_of_legislation:C2007C00653
Segment Type: clause
Provision Reference: sch 1 cl 41MEA
Character Range: 94403–95316

41MEA  Civil penalties for failing to apply conformity assessment procedures—manufacturers

Civil penalty relating to supplying a medical device

 (1) A person contravenes this subsection if:
 (a) the person supplies a medical device in Australia; and
 (b) the person has manufactured the device; and
 (c) the conformity assessment procedures have not been applied to the device.

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

 (2) A person contravenes this subsection if:
 (a) the person exports a medical device from Australia; and
 (b) the person has manufactured the device; and
 (c) the conformity assessment procedures have not been applied to the device.

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