THERAPEUTIC GOODS ACT 1989 - SECT 41BB Administrative processes (Parts 4 - 4 to 4 - 10)
THERAPEUTIC GOODS ACT 1989 - SECT 41BB
Administrative processes (Parts 4 - 4 to 4 - 10)The administrative processes under this Chapter are:
(a) issuing conformity assessment certificates for some manufacturers of medical devices; and
(aa) making conformity assessment body determinations; and
(b) including medical devices in the Register; and
(c) suspending or cancelling entries of medical devices from the Register; and
(ca) exempting medical devices from various provisions of this Chapter to deal with emergency situations; and
(d) exempting medical devices from the requirement to be included in the Register; and
(e) obtaining information about medical devices; and
(f) requiring public notification of problems with medical devices, and recall of such devices.
Note: Part 4 - 10 provides for assessment fees to be payable in
some circumstances.