Commonwealth Consolidated Acts Commonwealth Consolidated Acts(1) A person contravenes this section if:
(a) the person does any of the following:
(i) imports a medical device into Australia;
(ii) exports a medical device from Australia;
(iii) supplies a medical device in Australia;
(iv) manufactures a medical device in Australia; and
(b) none of the following subparagraphs apply 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.
Maximum civil penalty:
(a) for an individual--5,000 penalty units; and
(b) for a body corporate--50,000 penalty units.
Exception
(2) Subsection (1) does not apply 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.