Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 41BB

    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.