Commonwealth Consolidated Acts Commonwealth Consolidated Acts(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 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.
(5A) An offence against subsection (5) is an offence of strict liability.
Defence if person was not the sponsor of the goods
(6) It is a defence to a prosecution under subsection (1), (4) or (5) if the defendant proves that the defendant was not the sponsor of the device at the time of the importation, exportation, supply, or manufacture, as the case may be.
Note: A defendant bears a legal burden in relation to the matters in subsection (6): see section 13.4 of the Criminal Code .
Exception
(7) Subsection (1) does not apply if:
(a) harm or injury did not, will not, or is not likely to, directly result from:
(i) the quality, safety or performance of the medical device; or
(ii) a matter relating to the labelling or packaging of the medical device; or
(iii) the improper use of the medical device; or
(b) harm or injury would not, or would not be likely to, directly result from:
(i) the quality, safety or performance of the medical device; or
(ii) a matter relating to the labelling or packaging of the medical device; or
(iii) the improper use of the medical device.
Note: A defendant bears an evidential burden in relation to the matters in subsection (7): see subsection 13.3(3) of the Criminal Code .