Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 41MNB

  (1)   A person commits an offence if:

  (a)   the person does an act or omits to do an act in relation to a medical device; and

  (b)   the device is of a kind covered by an exemption in force under section   41GS; and

  (c)   the act or omission results in the breach of a condition of the exemption; and

  (d)   the act or omission is likely to cause a serious risk to public health.

Penalty:   Imprisonment for 5 years or 2,000 penalty units, or both.

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

  (2)   Strict liability applies to paragraph   (1)(b).

Note:   For strict liability, see section   6.1 of the Criminal Code .

  (3)   A person commits an offence if:

  (a)   the person does an act or omits to do an act in relation to a medical device; and

  (b)   the device is of a kind covered by an exemption in force under section   41GS; and

  (c)   the act or omission results in the breach of a condition of the exemption.

Penalty:   Imprisonment for 4 years or 240 penalty units, or both.

  (4)   Strict liability applies to paragraph   (3)(b).

Note:   For strict liability, see section   6.1 of the Criminal Code .

  (5)   A person commits an offence if:

  (a)   the person does an act or omits to do an act in relation to a medical device; and

  (b)   the device is of a kind covered by an exemption in force under section   41GS; and

  (c)   the act or omission results in the breach of a condition of the exemption.

Penalty:   60 penalty units.

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

Note:   For strict liability, see section   6.1 of the Criminal Code .