THERAPEUTIC GOODS ACT 1989 - SECT 41MN Criminal offences relating to breaches of conditions
THERAPEUTIC GOODS ACT 1989 - SECT 41MN
Criminal offences relating to breaches of conditionsOffences relating to breaching a condition of the inclusion of a kind of medical device in the Register
(1) A person commits an offence if:
(a) a kind of medical device is included in the Register in relation to the person; and
(b) the person does an act or omits to do an act; and
(c) the act or omission breaches a condition of the inclusion of the kind of device in the Register; and
(d) the act or omission has resulted in, will result in, or is likely to result in, harm or injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: 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.
Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
(4) A person commits an offence if:
(a) a kind of medical device is included in the Register in relation to the person; and
(b) the person does an act or omits to do an act; and
(c) the act or omission breaches a condition of the inclusion of the kind of device in the Register.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
(4A) A person commits an offence if:
(a) a kind of medical device is included in the Register in relation to the person; and
(b) the person does an act or omits to do an act; and
(c) the act or omission breaches a condition of the inclusion of the kind of device in the Register.
(4B) An offence against subsection (4A) is an offence of strict liability.
Offences relating to breaching a condition of a conformity assessment certificate
(5) A person commits an offence if:
(a) a conformity assessment certificate is issued in respect of the person; and
(b) the person does an act or omits to do an act; and
(c) the act or omission breaches a condition of the conformity assessment certificate; and
(d) the act or omission has resulted in, will result in, or is likely to result in, harm or injury to a 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) a conformity assessment certificate is issued in respect of the person; and
(b) the person does an act or omits to do an act; and
(c) the act or omission breaches a condition of the conformity assessment certificate.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
(8A) A person commits an offence if:
(a) a conformity assessment certificate is issued in respect of the person; and
(b) the person does an act or omits to do an act; and
(c) the act or omission breaches a condition of the conformity assessment certificate.
(8B) An offence against subsection (8A) is an offence of strict liability.
Offence relating to breaching a condition of an exemption or approval, or a condition applicable under regulations
(9) A person commits an offence if:
(a) the person does an act or omits to do an act; and
(b) the act or omission breaches:
(i) a condition of an exemption applicable under regulations made for the purposes of section 41HA; or
(ii) a condition of an approval under section 41HB; or
(iii) a condition applicable under regulations made for the purposes of subsection 41HB(7); or
(iv) a condition of an approval under subsection 41HD(1), (1A) or (2).
Offences relating to breaching a condition of a conformity assessment body determination
(10) An Australian corporation commits an offence if:
(a) the corporation does an act or omits to do an act; and
(b) the act or omission breaches a condition referred to in subsection 41EWA(5); and
(c) the act or omission has resulted in, will result in, or is likely to result in, harm or injury to any person.
Penalty: 20,000 penalty units.
(11) An Australian corporation commits an offence if:
(a) the corporation does an act or omits to do an act; and
(b) the act or omission breaches a condition referred to in subsection 41EWA(5).
(12) An Australian corporation commits an offence if:
(a) the corporation does an act or omits to do an act; and
(b) the act or omission breaches a condition referred to in subsection 41EWA(5).
(13) An offence against subsection (12) is an offence of
strict liability.