Document ID: chunk:federal_register_of_legislation:C2007C00652:clause:1_41me
Version: federal_register_of_legislation:C2007C00652
Segment Type: clause
Provision Reference: sch 1 cl 41ME
Character Range: 125893–126470

41ME  Failure to apply conformity assessment procedures—manufacturers

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

Maximum penalty: 240 penalty units.