Criminal offences for failing to apply conformity assessment procedures—sponsors
41MF Criminal offences for failing to apply conformity assessment procedures—sponsors
Offences relating to supplying a medical device
A person commits an offence if:
the person supplies a medical device in Australia; and
the conformity assessment procedures have not been applied to the device; and
the device is not of a kind covered by an exemption in force under section 41GS; and
either:
the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or
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; and
the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because the conformity assessment procedures have not been applied to the device.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (2) instead: see section 53A.
For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
A person commits an offence if:
the person supplies a medical device in Australia; and
the conformity assessment procedures have not been applied to the device; and
the device is not of a kind covered by an exemption in force under section 41GS.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
Offences relating to exporting a medical device
A person commits an offence if:
the person exports a medical device from Australia; and
the conformity assessment procedures have not been applied to the device; and
the device is not of a kind covered by an exemption in force under section 41GS; and
either:
the use of the device has resulted in, will result in, or is likely to result in, harm or injury to any person; or
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; and
the harm or injury has resulted, will result, is likely to result, would result, or would be likely to result, because the conformity assessment procedures have not been applied to the device.
Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.
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.
For the liability of an executive officer of a body corporate, see sections 54B and 54BA.
A person commits an offence if:
the person exports a medical device from Australia; and
the conformity assessment procedures have not been applied to the device; and
the device is not of a kind covered by an exemption in force under section 41GS.
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
Exception
This section does not apply if the defendant was not the sponsor of the device at the time of the supply or exportation, as the case may be.
A defendant bears an evidential burden in relation to the matters in subsection (5): see subsection 13.3(3) of the Criminal Code.
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