Document ID: chunk:federal_register_of_legislation:C2018A00007:clause:7_260
Version: federal_register_of_legislation:C2018A00007
Segment Type: clause
Provision Reference: sch 7 cl 260
Character Range: 205966–206879

260  Subsection 41MI(5)
Repeal the subsection, substitute:
 (5) A person commits an offence if:
 (a) the person:
 (i) imports a medical device into Australia; or
 (ii) exports a medical device from Australia; or
 (iii) supplies a medical device in Australia; or
 (iv) manufactures a medical device in Australia; and
 (b) none of the following subparagraphs applies in relation to the device:
 (i) the device is of a kind included in the Register in relation to the person;
 (ii) the device is of a kind covered by an exemption in force under section 41GS;
 (iii) the device is an exempt device;
 (iv) the device is the subject of an approval under section 41HB or an authority under section 41HC;
 (v) the device is the subject of an approval under subsection 41HD(1), (1A) or (2) that is held by the person.
Penalty: 100 penalty units.
 (5A) An offence against subsection (5) is an offence of strict liability.