Document ID: chunk:federal_register_of_legislation:C2024C00632:section:41mo:p3
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 41MO (pt 3/3)
Character Range: 870832–872696

Penalty: 100 penalty units.
 (4E) An offence against subsection (4D) is an offence of strict liability.
 (5) A person commits an offence if:
 (a) the person has been granted an approval under section 41HB relating to a specified medical device or specified kind of medical device; and
 (b) the person uses a medical device of that kind:
 (i) in the treatment of another person; or
 (ii) solely for experimental purposes in humans;
  otherwise than in accordance with the approval; 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.
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 (8) instead: see section 53A.
 (8) A person commits an offence if:
 (a) the person has been granted an approval under section 41HB relating to a specified medical device or specified kind of medical device; and
 (b) the person uses a medical device of that kind:
 (i) in the treatment of another person; or
 (ii) solely for experimental purposes in humans;
  otherwise than in accordance with the approval.
Penalty: 500 penalty units.
 (9) A person commits an offence if:
 (a) the person has been granted an approval under section 41HB relating to a specified medical device or specified kind of medical device; and
 (b) the person uses a medical device of that kind:
 (i) in the treatment of another person; or
 (ii) solely for experimental purposes in humans;
  otherwise than in accordance with the approval.
Penalty: 100 penalty units.
 (10) An offence against subsection (9) is an offence of strict liability.