Civil penalties for breaching conditions
41MNA Civil penalties for breaching conditions
A person contravenes this subsection if:
a kind of medical device is included in the Register in relation to the person; and
the person does an act or omits to do an act; and
the act or omission breaches a condition of the inclusion of the kind of device in the Register.
Maximum civil penalty:
for an individual—5,000 penalty units; and
for a body corporate—50,000 penalty units.
A person contravenes this subsection if:
a conformity assessment certificate is issued in respect of the person; and
the person does an act or omits to do an act; and
the act or omission breaches a condition of the conformity assessment certificate.
Maximum civil penalty:
for an individual—5,000 penalty units; and
for a body corporate—50,000 penalty units.
A person contravenes this subsection if:
the person does an act or omits to do an act; and
the act or omission breaches:
a condition of an exemption applicable under regulations made for the purposes of section 41HA; or
a condition of an approval under section 41HB; or
a condition applicable under regulations made for the purposes of subsection 41HB(7); or
a condition of an authority under section 41HC; or
a condition of an approval under subsection 41HD(1), (1A) or (2).
Maximum civil penalty:
for an individual—5,000 penalty units; and
for a body corporate—50,000 penalty units.
An Australian corporation contravenes this subsection if:
the corporation does an act or omits to do an act; and
the act or omission breaches a condition referred to in subsection 41EWA(5).
Maximum civil penalty: 50,000 penalty units.
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