Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 41EI

  (1)   A person commits an offence if:

  (a)   the person makes a statement (whether orally, in a document or in any other way); and

  (b)   the statement is made in or in connection with an application for a conformity assessment certificate; and

  (c)   the person knows that the statement is false or misleading in a material particular; and

  (d)   either:

  (i)   the use of the kind of medical device has resulted in, will result in, or is likely to result in, harm or injury to any person; or

  (ii)   the use of the kind of medical device, if the kind of medical device were used, would result in, or would be likely to result in, harm or injury to any person.

Penalty:   Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1:   A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection   (4) instead: see section   53A.

Note 2:   For the liability of an executive officer of a body corporate, see sections   54B and 54BA.

  (4)   A person commits an offence if:

  (a)   the person makes a statement (whether orally, in a document or in any other way); and

  (b)   the statement is in or in connection with an application for a conformity assessment certificate; and

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

Penalty:   Imprisonment for 12 months or 1,000 penalty units, or both.

  (5)   A person commits an offence if:

  (a)   the person makes a statement (whether orally, in a document or in any other way); and

  (b)   the statement is in or in connection with an application for a conformity assessment certificate; and

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

Penalty:   100 penalty units.

  (6)   An offence against subsection   (5) is an offence of strict liability.