Criminal offences for misusing medical devices exempted for special or experimental uses
41MO Criminal offences for misusing medical devices exempted for special or experimental uses
A person commits an offence if:
the person has been granted an authority under subsection 41HC(1) relating to a specified kind of medical device; and
the person supplies a medical device of that kind:
otherwise than in accordance with the authority; or
otherwise than in accordance with any conditions to which the authority is subject; or
otherwise than in accordance with any regulations made for the purpose of subsection 41HC(5); and
either:
the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or
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
the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because:
the supply is not in accordance with the authority; or
the supply is not in accordance with the conditions to which the authority is subject; or
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.
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.
A person commits an offence if:
the person has been granted an authority under subsection 41HC(1) relating to a specified kind of medical device; and
the person supplies a medical device of that kind:
otherwise than in accordance with the authority; or
otherwise than in accordance with any conditions to which the authority is subject; or
otherwise than in accordance with any regulations made for the purpose of subsection 41HC(5).
Penalty: 500 penalty units.
A person commits an offence if:
the person has been granted an authority under subsection 41HC(1) relating to a specified kind of medical device; and
the person supplies a medical device of that kind:
otherwise than in accordance with the authority; or
otherwise than in accordance with any conditions to which the authority is subject; or
otherwise than in accordance with any regulations made for the purpose of subsection 41HC(5).
Penalty: 100 penalty units.
An offence against subsection (4AA) is an offence of strict liability.
A person commits an offence if:
the person is a health practitioner; and
the person is included in a class of health practitioners specified in subsection 41HC(6) rules; and
the person supplies a medical device of a kind specified in those rules; and
any of the following applies:
the supply is not in accordance with those rules;
the supply is not in the circumstances specified in those rules;
the supply is not in accordance with the conditions specified in those rules; and
either:
the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or
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
the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because:
the supply is not in accordance with those rules; or
the supply is not in the circumstances specified in those rules; or
the supply is not in accordance with the conditions specified in those rules.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
A person commits an offence if:
the person is a health practitioner; and
the person is included in a class of health practitioners specified in subsection 41HC(6) rules; and
the person supplies a medical device of a kind specified in those rules; and
any of the following applies:
the supply is not in accordance with those rules;
the supply is not in the circumstances specified in those rules;
the supply is not in accordance with the conditions specified in those rules.
Penalty: 500 penalty units.
A person commits an offence if:
the person is a health practitioner; and
the person is included in a class of health practitioners specified in subsection 41HC(6) rules; and
the person supplies a medical device of a kind specified in those rules; and
any of the following applies:
the supply is not in accordance with those rules;
the supply is not in the circumstances specified in those rules;
the supply is not in accordance with the conditions specified in those rules.
Penalty: 100 penalty units.
An offence against subsection (4D) is an offence of strict liability.
A person commits an offence if:
the person has been granted an approval under section 41HB relating to a specified medical device or specified kind of medical device; and
the person uses a medical device of that kind:
in the treatment of another person; or
solely for experimental purposes in humans;
otherwise than in accordance with the approval; and
either:
the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or
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.
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.
A person commits an offence if:
the person has been granted an approval under section 41HB relating to a specified medical device or specified kind of medical device; and
the person uses a medical device of that kind:
in the treatment of another person; or
solely for experimental purposes in humans;
otherwise than in accordance with the approval.
Penalty: 500 penalty units.
A person commits an offence if:
the person has been granted an approval under section 41HB relating to a specified medical device or specified kind of medical device; and
the person uses a medical device of that kind:
in the treatment of another person; or
solely for experimental purposes in humans;
otherwise than in accordance with the approval.
Penalty: 100 penalty units.
An offence against subsection (9) is an offence of strict liability.
This provision refers to the regulations (any regulations
). Made under this Act:
- Therapeutic Goods (Medical Devices) Regulations 2002 · under s 63
- Therapeutic Goods Regulations 1990 · under s 63
5 more instruments made under this Act are listed on the Act’s overview.
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