Document ID: chunk:federal_register_of_legislation:C2010A00141:clause:1_41hd:p1
Version: federal_register_of_legislation:C2010A00141
Segment Type: clause
Provision Reference: sch 1 cl 41HD (pt 1/2)
Character Range: 4330–7120

41HD  Approvals if substitutes for medical devices are unavailable or in short supply
 (1) The Secretary may, by notice in writing, grant an approval to a person for:
 (a) the importation into Australia of a specified medical device; or
 (b) the importation into Australia of a specified medical device and the supply in Australia of that device;
if the Secretary is satisfied that:
 (c) the kinds of medical devices included in the Register that could act as a substitute for the medical device are unavailable or are in short supply; and
 (d) either:
 (i) the medical device is registered or approved for general marketing in at least one foreign country specified in a determination under subsection (5); or
 (ii) an application has been made in accordance with section 41FC for inclusion in the Register of the kind of medical device that includes the medical device; and
 (e) the medical device is specified in a determination under subsection (6); and
 (f) the approval is necessary in the interests of public health.
Note: For specification by class, see the Acts Interpretation Act 1901 and subsection 13(3) of the Legislative Instruments Act 2003.
 (2) The Secretary may, by notice in writing, grant an approval to a person for:
 (a) the importation into Australia of a specified medical device; or
 (b) the importation into Australia of a specified medical device and the supply in Australia of that device;
if the Secretary is satisfied that:
 (c) there are no kinds of medical devices that are included in the Register that could act as a substitute for the medical device; and
 (d) an application has been made in accordance with section 41FC for inclusion in the Register of the kind of medical device that includes the medical device; and
 (e) the medical device is specified in a determination under subsection (6); and
 (f) the approval is necessary in the interests of public health.
Note: For specification by class, see the Acts Interpretation Act 1901 and subsection 13(3) of the Legislative Instruments Act 2003.

Application for approval
 (3) An application for an approval must:
 (a) be made to the Secretary; and
 (b) be accompanied by such information relating to the medical device as is required by the Secretary.

Notification of Secretary's decision
 (4) If an application for an approval is made, the Secretary must, as soon as practicable after deciding the application, notify the applicant of:
 (a) the decision; and
 (b) if the decision is not to 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