Document ID: chunk:federal_register_of_legislation:C2024C00632:section:41mna
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 41MNA
Character Range: 861636–863458

41MNA  Civil penalties for breaching conditions
 (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.

Division 3A—Offences and civil penalties related to exemptions under Part 4‑6A