Document ID: chunk:federal_register_of_legislation:C2007C00653:clause:1_41mi:p1
Version: federal_register_of_legislation:C2007C00653
Segment Type: clause
Provision Reference: sch 1 cl 41MI (pt 1/2)
Character Range: 99080–101708

41MI  Criminal offences for importing, exporting, supplying or manufacturing a medical device not included in the Register

 (1) 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 an exempt device;
 (iii) the device is the subject of an approval under section 41HB or an authority under section 41HC; and
 (c) either:
 (i) the use of the device has resulted in, or will result in, harm or injury to any person; or
 (ii) the use of the device, if the device were used, would result in harm or injury to any person.

Maximum penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

 (2) 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 an exempt device;
 (iii) the device is the subject of an approval under section 41HB or an authority under section 41HC; and
 (c) the use of the device, if the device were used, would be likely to result in harm or injury to any person.

Maximum penalty: 2,000 penalty units.

 (3) Subsection (2) is an offence of strict liability.

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

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

Maximum penalty: Imprisonment for 12 months or 1,000 penalty units, or both.

 (5) Strict liability applies