Document ID: chunk:federal_register_of_legislation:C2010A00141:clause:1_41hd:p2
Version: federal_register_of_legislation:C2010A00141
Segment Type: clause
Provision Reference: sch 1 cl 41HD (pt 2/2)
Character Range: 6812–8599

grant the approval—the reasons for the decision.

Determinations
 (5) The Secretary may, by legislative instrument, make a determination specifying foreign countries for the purposes of subparagraph (1)(d)(i).
 (6) The Secretary may, by legislative instrument, make a determination specifying medical devices that can be the subject of an approval under this section.

Conditions
 (7) The Secretary may grant an approval subject to any conditions that are specified in the notice of approval.
Note: Breach of the conditions may be an offence: see subsection 41MN(9).

Period of approval
 (8) The Secretary may grant an approval for such period as is specified in the notice of approval.

When approval lapses
 (9) The approval lapses if:
 (a) the period specified in the notice of approval expires; or
 (b) a decision has been made on an application that has been made for inclusion in the Register of the kind of medical device that includes the medical device.
 (10) The approval lapses if:
 (a) the Secretary is satisfied that paragraph (1)(c), (d), (e) or (f), or paragraph (2)(c), (d), (e) or (f), as the case requires, no longer applies in relation to the medical device, or that a condition of the approval has been contravened; and
 (b) the Secretary has given to the person to whom the approval was granted a notice stating that the Secretary is so satisfied.
 (11) The lapsing of the approval on the expiry of the period specified in the notice of approval does not prevent another approval being granted under this section in relation to the medical device before that lapsing. The other approval may be expressed to take effect on the expiry of that period.

Approval not a legislative instrument
 (12) An approval under subsection (1) or (2) is not a legislative instrument.