Document ID: chunk:federal_register_of_legislation:C2024C00632:section:41mea
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 41MEA
Character Range: 835773–836860

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; and
 (d) the device is not of a kind covered by an exemption in force under section 41GS.
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; and
 (d) the device is not of a kind covered by an exemption in force under section 41GS.
Maximum civil penalty:
 (a) for an individual—5,000 penalty units; and
 (b) for a body corporate—50,000 penalty units.