Document ID: chunk:federal_register_of_legislation:C2007C00653:clause:1_41mf
Version: federal_register_of_legislation:C2007C00653
Segment Type: clause
Provision Reference: sch 1 cl 41MF
Character Range: 95367–97927

41MF  Criminal offences for failing to apply conformity assessment procedures—sponsors

Offences relating to supplying a medical device

 (1) A person commits an offence if:
 (a) the person supplies a medical device in Australia; and
 (b) the conformity assessment procedures have not been applied to the device; and
 (c) either:
 (i) the use of the device has resulted in, or will result in, harm or injury to any person; or
 (ii) the use of the device, if the device were used, would result in harm or injury to any person; and
 (d) the harm or injury has resulted, will result, or would result, because the conformity assessment procedures have not been applied to the device.

Maximum 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 (2) instead: see section 53A.

 (2) A person commits an offence if:
 (a) the person supplies a medical device in Australia; and
 (b) the conformity assessment procedures have not been applied to the device.

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

Offences relating to exporting a medical device

 (3) A person commits an offence if:
 (a) the person exports a medical device from Australia; and
 (b) the conformity assessment procedures have not been applied to the device; and
 (c) either:
 (i) the use of the device has resulted in, or will result in, harm or injury to any person; or
 (ii) the use of the device, if the device were used, would result in harm or injury to any person; and
 (d) the harm or injury has resulted, will result, or would result, because the conformity assessment procedures have not been applied to the device.

Maximum 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.

 (4) A person commits an offence if:
 (a) the person exports a medical device from Australia; and
 (b) the conformity assessment procedures have not been applied to the device.

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

Exception

 (5) This section does not apply if the defendant was not the sponsor of the device at the time of the supply or exportation, as the case may be.

Note: A defendant bears an evidential burden in relation to the matters in subsection (5): see subsection 13.3(3) of the Criminal Code.