Document ID: chunk:federal_register_of_legislation:C2007C00652:clause:1_41mf
Version: federal_register_of_legislation:C2007C00652
Segment Type: clause
Provision Reference: sch 1 cl 41MF
Character Range: 126470–127256

41MF  Failure to apply conformity assessment procedures—sponsors

 (1) A person is guilty of an offence if:
 (a) the person supplies a medical device in Australia; and
 (b) the conformity assessment procedures have not been applied to the device.

Maximum penalty: 240 penalty units.

 (2) A person is guilty of an offence if:
 (a) the person exports a medical device from Australia; and
 (b) the conformity assessment procedures have not been applied to the device.

Maximum penalty: 240 penalty units.

 (3) This section does not apply if the defendant was not the sponsor of the device at the time of the supply or export, as the case may be.

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