Civil penalties for failing to apply conformity assessment procedures—manufacturers
41MEA Civil penalties for failing to apply conformity assessment procedures—manufacturers
Civil penalty relating to supplying a medical device
A person contravenes this subsection if:
the person supplies a medical device in Australia; and
the person has manufactured the device; 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.
Maximum civil penalty:
for an individual—5,000 penalty units; and
for a body corporate—50,000 penalty units.
Civil penalty relating to exporting a medical device
A person contravenes this subsection if:
the person exports a medical device from Australia; and
the person has manufactured the device; 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.
Maximum civil penalty:
for an individual—5,000 penalty units; and
for a body corporate—50,000 penalty units.
This Act’s bill:Second reading speech
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