Therapeutic Goods Act 1989

The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, suspend the kind of device from the Register if:

the Secretary is satisfied that:

there is a potential risk of death, serious illness or serious injury if the kind of device continues to be included in the Register; and

it is likely that the person will, within the period of the suspension, be able to take the action necessary to ensure that the kind of device would not cause a potential risk of death, serious illness or serious injury if it were to continue to be included in the Register; or

the Secretary is satisfied that it is likely that there are grounds for cancelling the entry of the kind of device from the Register under Division 2 (other than under paragraph 41GL(a), (d) or (f) or section 41GM).

The suspension may be limited to some medical devices of that kind, as specified in the notice.

The notice must specify the period of the suspension. The period must not exceed 6 months.

The period of the suspension may be extended under section 41GC.

The Secretary must cause to be published in the Gazette or on the Department’s website, as soon as practicable after the suspension, a notice setting out particulars of the suspension.