Document ID: chunk:federal_register_of_legislation:C2018A00007:clause:7_245
Version: federal_register_of_legislation:C2018A00007
Segment Type: clause
Provision Reference: sch 7 cl 245
Character Range: 203593–204048

245  After subsection 41ME(4)
Insert:
 (4A) A person commits an offence if:
 (a) the person manufactures a medical device; and
 (b) the person supplies the device in Australia; and
 (c) the conformity assessment procedures have not been applied to the device; and
 (d) the device is not of a kind covered by an exemption in force under section 41GS.
Penalty: 100 penalty units.
 (4B) An offence against subsection (4A) is an offence of strict liability.