Document ID: chunk:federal_register_of_legislation:C2024C00632:section:41hd:p1
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 41HD (pt 1/3)
Character Range: 773344–776098

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 the application has passed preliminary assessment; 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 Legislation Act 2003.
 (1A) 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 not registered or approved for general marketing in any of the foreign countries specified in a determination under subsection (5); or
 (ii) the medical device is registered or approved for general marketing in at least one foreign country specified in a determination under subsection (5), but is not readily available for importation into, and supply in, Australia; and
 (e) the medical device is registered or approved for general marketing in a foreign country; and
 (f) the manufacturing and quality control procedures used in the manufacture of the medical device are acceptable; and
 (g) the medical device is specified in a determination under subsection (6); and
 (h) 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 Legislation 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