Civil penalty relating to supplying a medical device
(1) A person contravenes this subsection if:
(a) the person supplies a medical device in Australia; and
(b) the person has manufactured the device; and
(c) the conformity assessment procedures have not been applied to the device; and
(d) the device is not of a kind covered by an exemption in force under section 41GS.
Maximum civil penalty:
(a) for an individual--5,000 penalty units; and
(b) for a body corporate--50,000 penalty units.
Civil penalty relating to exporting a medical device
(2) A person contravenes this subsection if:
(a) the person exports a medical device from Australia; and
(b) the person has manufactured the device; and
(c) the conformity assessment procedures have not been applied to the device; and
(d) the device is not of a kind covered by an exemption in force under section 41GS.
Maximum civil penalty:
(a) for an individual--5,000 penalty units; and
(b) for a body corporate--50,000 penalty units.