Commonwealth Consolidated Acts

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THERAPEUTIC GOODS ACT 1989 - SECT 41FP

Conditions imposed after kinds of medical devices are included in the Register

             (1)  The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register:

                     (a)  impose new conditions on including the kind of device in the Register under this Chapter; or

                     (b)  vary or remove existing conditions.

The power may be exercised at the person's request or on the Secretary's own initiative.

             (2)  The imposition, variation or removal of a condition under this section takes effect:

                     (a)  if the notice states that the action is necessary to prevent imminent risk of death, serious illness or serious injury--on the day on which the notice is given to the person; or

                    (aa)  in the case of an imposition or variation requested by the person, and to which paragraph (a) does not apply--on the day specified in the notice, which must be at least 20 working days after the notice is given to the person, unless the person has agreed to an earlier day; or

                   (ab)  in the case of a removal to which paragraph (a) does not apply--on the day specified in the notice, which must be at least 20 working days after the notice is given to the person, unless the person has agreed to an earlier day; or

                     (b)  in any other case--on the day specified for the purpose in the notice, being a day not earlier than 20 working days after the notice is given to the person.

             (3)  For the purposes of paragraphs (2)(aa) and (ab), the earlier day must not be earlier than the day the notice is given to the person.



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