Document ID: chunk:federal_register_of_legislation:C2007C00653:clause:1_41mi:p2
Version: federal_register_of_legislation:C2007C00653
Segment Type: clause
Provision Reference: sch 1 cl 41MI (pt 2/2)
Character Range: 101465–102906

the device is an exempt device;
 (iii) the device is the subject of an approval under section 41HB or an authority under section 41HC.

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

 (5) Strict liability applies to paragraph (4)(b).

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

Defence if person was not the sponsor of the goods

 (6) It is a defence to a prosecution under subsection (1), (2) or (4) if the defendant proves that the defendant was not the sponsor of the device at the time of the importation, exportation, supply, or manufacture, as the case may be.

Note: A defendant bears a legal burden in relation to the matters in subsection (6): see section 13.4 of the Criminal Code.

Exception

 (7) Subsection (1) does not apply if:
 (a) harm or injury did not, or will not, directly result from:
 (i) the quality, safety or performance of the medical device; or
 (ii) a matter relating to the labelling or packaging of the medical device; or
 (iii) the improper use of the medical device; or
 (b) harm or injury would not directly result from:
 (i) the quality, safety or performance of the medical device; or
 (ii) a matter relating to the labelling or packaging of the medical device; or
 (iii) the improper use of the medical device.

Note: A defendant bears an evidential burden in relation to the matters in subsection (7): see subsection 13.3(3) of the Criminal Code.