Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 41MK

                   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.