Document ID: chunk:federal_register_of_legislation:C2024C00632:section:41mi:p1
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 41MI (pt 1/2)
Character Range: 842573–845135

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;
 (ia) the device is of a kind covered by an exemption in force under section 41GS;
 (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;
 (iv) the device is the subject of an approval under subsection 41HD(1), (1A) or (2) that is held by the person; and
 (c) either:
 (i) the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or
 (ii) the use of the device, if the device were used, would result in, or would be likely to result in, harm or injury to any person.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
Note 1: 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.
Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
 (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;
 (ia) the device is of a kind covered by an exemption in force under section 41GS;
 (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;
 (iv) the device is the subject of an approval under subsection 41HD(1), (1A) or (2) that is held by the person.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
 (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