Document ID: chunk:federal_register_of_legislation:C2024C00632:section:41mo:p1
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 41MO (pt 1/3)
Character Range: 866050–868725

41MO  Criminal offences for misusing medical devices exempted for special or experimental uses
 (1) A person commits an offence if:
 (a) the person has been granted an authority under subsection 41HC(1) relating to a specified kind of medical device; and
 (b) the person supplies a medical device of that kind:
 (i) otherwise than in accordance with the authority; or
 (ii) otherwise than in accordance with any conditions to which the authority is subject; or
 (iii) otherwise than in accordance with any regulations made for the purpose of subsection 41HC(5); and
 (c) either:
 (i) the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or
 (ii) the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person; and
 (d) the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because:
 (i) the supply is not in accordance with the authority; or
 (ii) the supply is not in accordance with the conditions to which the authority is subject; or
 (iii) the supply is not in accordance with regulations made for the purpose of subsection 41HC(5).
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.
 (4) A person commits an offence if:
 (a) the person has been granted an authority under subsection 41HC(1) relating to a specified kind of medical device; and
 (b) the person supplies a medical device of that kind:
 (i) otherwise than in accordance with the authority; or
 (ii) otherwise than in accordance with any conditions to which the authority is subject; or
 (iii) otherwise than in accordance with any regulations made for the purpose of subsection 41HC(5).
Penalty: 500 penalty units.
 (4AA) A person commits an offence if:
 (a) the person has been granted an authority under subsection 41HC(1) relating to a specified kind of medical device; and
 (b) the person supplies a medical device of that kind:
 (i) otherwise than in accordance with the authority; or
 (ii) otherwise than in accordance with any conditions to which the authority is subject; or
 (iii) otherwise than in accordance with any regulations made for the purpose of subsection 41HC(5).
Penalty: 100 penalty units.
 (4AB) An offence against subsection (4AA) is an offence of strict liability.
 (4A) A person commits an offence if:
 (a) the person is a health practitioner; and
 (b) the person is included in a class of health practitioners specified in