Document ID: chunk:federal_register_of_legislation:C2024C00632:section:41mk
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 41MK
Character Range: 851990–852747

41MK  Wholesale supply of medical devices not included in the Register
  A person commits an offence if:
 (a) the person supplies a medical device in Australia; and
 (b) none of the following subparagraphs applies in relation to the device:
 (i) the device is of a kind included in the Register;
 (ia) the device is of a kind covered by an exemption in force under section 41GS;
 (ii) the device is an exempt device;
 (iii) the device is the subject of an approval under section 41HB or an authority under section 41HC;
 (iv) the device is the subject of an approval under subsection 41HD(1), (1A) or (2) that is held by the person; and
 (c) the person to whom the device is supplied is not the ultimate consumer of the device.
Penalty: 120 penalty units.