Document ID: chunk:federal_register_of_legislation:C2007C00653:clause:1_41me:p1
Version: federal_register_of_legislation:C2007C00653
Segment Type: clause
Provision Reference: sch 1 cl 41ME (pt 1/2)
Character Range: 90680–93348

41ME  Criminal offences for failing to apply conformity assessment procedures—manufacturers

Offences relating to supplying a medical device

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

 (2) A person commits an offence if:
 (a) the person manufactures a medical device; and
 (b) the person supplies the device in Australia; and
 (c) the conformity assessment procedures have not been applied to the device; and
 (d) the use of the device, if the device were used, would be likely to result in harm or injury to any person; and
 (e) the harm or injury would be likely to result because the conformity assessment procedures have not been applied to the device.

Maximum 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) the person manufactures a medical device; and
 (b) the person supplies the device in Australia; and
 (c) 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

 (5) A person commits an offence if:
 (a) the person manufactures a medical device; and
 (b) the person exports the device from Australia; and
 (c) the conformity assessment procedures have not been applied to the device; and
 (d) 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
 (e) 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