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THERAPEUTIC GOODS ACT 1989 - SECT 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 subsection   41HC(6) rules; and

  (c)   the person supplies a medical device of a kind specified in those rules; and

  (d)   any of the following applies:

  (i)   the supply is not in accordance with those rules;

  (ii)   the supply is not in the circumstances specified in those rules;

  (iii)   the supply is not in accordance with the conditions specified in those rules; and

  (e)   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

  (f)   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 those rules; or

  (ii)   the supply is not in the circumstances specified in those rules; or

  (iii)   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.

  (4C)   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 subsection   41HC(6) rules; and

  (c)   the person supplies a medical device of a kind specified in those rules; and

  (d)   any of the following applies:

  (i)   the supply is not in accordance with those rules;

  (ii)   the supply is not in the circumstances specified in those rules;

  (iii)   the supply is not in accordance with the conditions specified in those rules.

Penalty:   500 penalty units.

  (4D)   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 subsection   41HC(6) rules; and

  (c)   the person supplies a medical device of a kind specified in those rules; and

  (d)   any of the following applies:

  (i)   the supply is not in accordance with those rules;

  (ii)   the supply is not in the circumstances specified in those rules;

  (iii)   the supply is not in accordance with the conditions specified in those rules.

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.

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