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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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