Commonwealth Consolidated Regulations Commonwealth Consolidated RegulationsFor subsection 41FN(4) of the Act, the information required for the purposes of paragraph 41FN(3)(e) of the Act in relation to a kind of medical device that is included in the Register in relation to a person is:
(a) any information that the person is aware of relating to:
(i) any malfunction or deterioration in the characteristics or performance of the kind of device; or
(ii) any inadequacy in the design, manufacture, 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 has led to any complaint or problem in relation to the kind of device, no matter how minor; and
(b) any information of the kind mentioned in subsection 41MP(2) of the Act that the person is aware of in relation to the kind of device.