Document ID: chunk:federal_register_of_legislation:C2007C00652:clause:1_41mi
Version: federal_register_of_legislation:C2007C00652
Segment Type: clause
Provision Reference: sch 1 cl 41MI
Character Range: 128577–129721

41MI  Importation, exportation, supply or manufacture of medical devices not included in the Register

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

Maximum penalty: 240 penalty units.

 (2) Strict liability applies to paragraph (1)(b).

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

 (3) Subsection (1) does not apply if the defendant proves that the defendant was not the sponsor of the device at the time of the importation, export, supply, or manufacture, as the case may be.

Note: A defendant bears a legal burden in relation to the matters in subsection (3) (see section 13.4 of the Criminal Code).