Commonwealth Consolidated Acts

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Civil penalty for failing to notify adverse events etc.

             (1)  A person contravenes this section if:

                     (a)  a kind of medical device is included in the Register in relation to the person; and

                     (b)  the information is of a kind mentioned in subsection (2); and

                     (c)  the person does not give information of a kind mentioned in subsection (2) 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).

Maximum civil penalty:

                     (a)  for an individual--3,000 penalty units; and

                     (b)  for a body corporate--30,000 penalty units.

             (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 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 recall 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 or other document (other than a certificate or other document issued by the Secretary 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 device of that kind or the application of requirements, comparable to those procedures, to a device of that kind;

                            has been restricted, suspended, revoked or is no longer in effect.

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