Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 41MN

Offences relating to breaching a condition of the inclusion of a kind of medical device in the Register

             (1)  A person commits an offence if:

                     (a)  a kind of medical device is included in the Register in relation to the person; and

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

                     (c)  the act or omission breaches a condition of the inclusion of the kind of device in the Register; and

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

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

Note:          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.

             (2)  A person commits an offence if:

                     (a)  a kind of medical device is included in the Register in relation to the person; and

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

                     (c)  the act or omission breaches a condition of the inclusion of the kind of device in the Register; and

                     (d)  the act or omission is likely to result in harm or injury to any person.

Penalty:  2,000 penalty units.

             (3)  Subsection (2) is an offence of strict liability.

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

             (4)  A person commits an offence if:

                     (a)  a kind of medical device is included in the Register in relation to the person; and

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

                     (c)  the act or omission breaches a condition of the inclusion of the kind of device in the Register.

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

Offences relating to breaching a condition of a conformity assessment certificate

             (5)  A person commits an offence if:

                     (a)  a conformity assessment certificate is issued in respect of the person; and

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

                     (c)  the act or omission breaches a condition of the conformity assessment certificate; and

                     (d)  the act or omission has resulted in, or will result in, harm or injury to a person.

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

Note:          A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (8) instead: see section 53A.

             (6)  A person commits an offence if:

                     (a)  a conformity assessment certificate is issued in respect of the person; and

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

                     (c)  the act or omission breaches a condition of the conformity assessment certificate; and

                     (d)  the act or omission is likely to result in harm or injury to a person.

Penalty:  2,000 penalty units.

             (7)  Subsection (6) is an offence of strict liability.

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

             (8)  A person commits an offence if:

                     (a)  a conformity assessment certificate is issued in respect of the person; and

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

                     (c)  the act or omission breaches a condition of the conformity assessment certificate.

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

Offence relating to breaching a condition of an exemption or approval, or a condition applicable under regulations

             (9)  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:

                              (i)  a condition of an exemption applicable under regulations made for the purposes of section 41HA; or

                             (ii)  a condition of an approval under section 41HB; or

                            (iii)  a condition applicable under regulations made for the purposes of subsection 41HB(7); or

                            (iv)  a condition of an approval under subsection 41HD(1) or (2).

Penalty:  60 penalty units.