Document ID: chunk:federal_register_of_legislation:C2007C00653:clause:1_41ma:p3
Version: federal_register_of_legislation:C2007C00653
Segment Type: clause
Provision Reference: sch 1 cl 41MA (pt 3/3)
Character Range: 85492–86772

section 53A.

 (10) A person commits an offence if:
 (a) the person exports a medical device from Australia; and
 (b) the medical device does not comply with the essential principles; and
 (c) the Secretary has not consented to the exportation; 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.

 (11) Subsection (10) is an offence of strict liability.

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

 (12) A person commits an offence if:
 (a) the person exports a medical device from Australia; and
 (b) the medical device does not comply with the essential principles; and
 (c) the Secretary has not consented to the exportation.

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

Exception

 (13) Paragraphs (9)(b), (10)(b) and (12)(b) do not apply to the extent that the essential principles in question relate to labelling medical devices for supply in Australia.

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