Commonwealth Consolidated Acts Commonwealth Consolidated Acts(1) A person contravenes this subsection 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.
Maximum civil penalty:
(a) for an individual--5,000 penalty units; and
(b) for a body corporate--50,000 penalty units.
(2) A person contravenes this subsection 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.
Maximum civil penalty:
(a) for an individual--5,000 penalty units; and
(b) for a body corporate--50,000 penalty units.
(2A) A person contravenes this subsection 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
(iiia) a condition of an authority under section 41HC; or
(iv) a condition of an approval under subsection 41HD(1), (1A) or (2).
Maximum civil penalty:
(a) for an individual--5,000 penalty units; and
(b) for a body corporate--50,000 penalty units.
(3) An Australian corporation contravenes this subsection 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).
Maximum civil penalty: 50,000 penalty units.