Document ID: chunk:federal_register_of_legislation:C2007C00653:clause:1_41ma:p1
Version: federal_register_of_legislation:C2007C00653
Segment Type: clause
Provision Reference: sch 1 cl 41MA (pt 1/3)
Character Range: 80713–83333

41MA  Criminal offences for importing, supplying or exporting a medical device that does not comply with essential principles

Offences relating to importing a medical device

 (1) A person commits an offence if:
 (a) the person imports a medical device into Australia; and
 (b) the medical device does not comply with the essential principles relating to matters other than the labelling of the device; and
 (c) the Secretary has not consented to the importation; 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 device does not comply with the essential principles.

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 imports a medical device into Australia; and
 (b) the medical device does not comply with the essential principles relating to matters other than the labelling of the device; and
 (c) the Secretary has not consented to the importation; 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 device does not comply with the essential principles.

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 imports a medical device into Australia; and
 (b) the medical device does not comply with the essential principles relating to matters other than the labelling of the device; and
 (c) the Secretary has not consented to the importation.

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

Offences relating to supplying a medical device

 (5) A person commits an offence if:
 (a) the person supplies a medical device for use in Australia; and
 (b) the medical device does not comply with the essential principles; and
 (c) the Secretary has not consented to the supply; 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 device were used, would result in harm or injury to any person; and
 (e) the harm