A person commits an offence if:
(a) the person supplies a medical device in Australia; and
(b) none of the following subparagraphs applies in relation to the device:
(i) the device is of a kind included in the Register;
(ia) the device is of a kind covered by an exemption in force under section 41GS;
(ii) the device is an exempt device;
(iii) the device is the subject of an approval under section 41HB or an authority under section 41HC;
(iv) the device is the subject of an approval under subsection 41HD(1), (1A) or (2) that is held by the person; and
(c) the person to whom the device is supplied is not the ultimate consumer of the device.
Penalty: 120 penalty units.