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.