Document ID: chunk:federal_register_of_legislation:C2007C00652:clause:1_41ma
Version: federal_register_of_legislation:C2007C00652
Segment Type: clause
Provision Reference: sch 1 cl 41MA
Character Range: 122543–123926

41MA  Non‑compliance with essential principles

 (1) A person is guilty of 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: 240 penalty units.

 (2) A person is guilty of 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.

Maximum penalty: 240 penalty units.

 (3) A person is guilty of 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: 240 penalty units.

 (4) Paragraph (3)(b) does 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).

 (5) The Secretary must not give consent relating to an exportation unless satisfied that there are exceptional circumstances that justify giving the consent.