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THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002 2002 No. 236 - REG 5.8
Conditions applying automatically — requirements in relation to information about kind of medical device (Act s 41FN)
For 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.
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