THERAPEUTIC GOODS ACT 1989 - SECT 41GK Automatic cancellation of entries of kinds of medical devices from the Register
THERAPEUTIC GOODS ACT 1989 - SECT 41GK
Automatic cancellation of entries of kinds of medical devices from the Register(1) The Secretary must, by written notice given to the person in relation to whom a kind of medical device is included in the Register, cancel the entry of the kind of device from the Register if:
(a) the kind of device has been suspended from the Register under section 41GA, and the period applying to the suspension under subsection 41GA(3) or 41GC(3) (as the case requires) expires before the suspension is revoked under section 41GD; or
(b) a conformity assessment certificate applying to that kind of device is revoked under Division 4 of Part 4 - 4.
(2) The Secretary must, by written notice given to the person in relation to whom a kind of medical device is included in the Register, cancel the entry of the kind of device from the Register if the Secretary is satisfied that:
(a) if there are one or more absolute prohibitions in force for the purposes of subsection 9K(1) or (3)--imports into Australia, exports from Australia, the manufacture in Australia or supplies in Australia of the kind of device would contravene one or more of those prohibitions; or
(b) if there are one or more prohibitions in force for the
purposes of subsection 9K(1) or (3) that are subject to
conditions--imports into Australia, exports from Australia, the manufacture in
Australia or supplies in Australia of the kind of device would contravene one
or more of those conditions.