Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 41MC

  (1)   The consent of the Secretary under section   41MA or 41MAA may be given:

  (a)   unconditionally or subject to conditions; or

  (b)   in respect of particular medical devices or kinds of medical devices.

  (2)   A person commits an offence if:

  (a)   the person does an act or omits to do an act; and

  (b)   the act or omission breaches a condition of a consent; and

  (c)   the act or omission has resulted in, will result in, or is likely to result in, harm or injury to any person.

Penalty:   2,000 penalty units.

Note 1:   A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection   (5) instead: see section   53A.

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

  (5)   A person commits an offence if:

  (a)   the person does an act or omits to do an act; and

  (b)   the act or omission breaches a condition of a consent.

Penalty:   500 penalty units.

  (6)   A person commits an offence if:

  (a)   the person does an act or omits to do an act; and

  (b)   the act or omission breaches a condition of a consent.

Penalty:   100 penalty units.

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