Commonwealth Consolidated Acts Commonwealth Consolidated Acts(1) A person is guilty of an offence if:
(a) the person is a person in relation to whom a kind of medical device is included in the Register; and
(b) the person knows that particular information is information of a kind mentioned in subsection (2); and
(c) the person fails to give that information to the Secretary within the period specified in the regulations (whether or not the person has already given to the Secretary other information relating to the same matter).
Penalty: Imprisonment for 12 months or 1,000 penalty units, or both.
(2) The information with which subsection (1) is concerned is information of the following kinds:
(a) information relating to:
(i) any malfunction or deterioration in the characteristics or performance of the kind of device; or
(ii) any inadequacy in the design, production, labelling, instructions for use or advertising materials of the kind of device; or
(iii) any use in accordance with, or contrary to, the use intended by the manufacturer of the kind of device;
that might lead, or might have led, to the death of a patient or a user of the device, or to a serious deterioration in his or her state of health;
(b) information relating to any technical or medical reason for a malfunction or deterioration of a kind referred to in subparagraph (a)(i) that has led the manufacturer to take steps to recover devices of that kind that have been distributed;
(c) information that indicates that a device of that kind does not comply with the essential principles;
(d) information that indicates that a certificate (other than one issued under this Act) used for the purpose of an application under subsection 41FC(1) to signify:
(i) compliance with the essential principles; or
(ii) the application of relevant conformity assessment procedures to a particular device;
has been restricted, suspended, revoked or is no longer in effect.
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