Document ID: chunk:federal_register_of_legislation:C2007C00653:clause:1_41mo:p2
Version: federal_register_of_legislation:C2007C00653
Segment Type: clause
Provision Reference: sch 1 cl 41MO (pt 2/2)
Character Range: 115453–117857

Code.

 (4) A person commits an offence if:
 (a) the person has been granted an authority under section 41HC 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).

Maximum penalty: 500 penalty units.

 (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, or will result in, harm or injury to any person; or
 (ii) the use of the device, if the device were used, would result in harm or injury to any person.

Maximum 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.

 (6) 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) the use of the device, if the device were used, would be likely to result in harm or injury to any person.

Maximum penalty: 2,000 penalty units.

 (7) Subsection (6) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

 (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.

Maximum penalty: 500 penalty units.