Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 41MHA

    A person contravenes this section if:

  (a)   the person manufactures a medical device; and

  (b)   the person makes a statement in or in connection with a declaration relating to the application of conformity assessment procedures, or the application of requirements comparable to those procedures, to the device; and

  (c)   the statement is false or misleading in a material particular.

Maximum civil penalty:

  (a)   for an individual--3,000 penalty units; and

  (b)   for a body corporate--30,000 penalty units.