Document ID: chunk:federal_register_of_legislation:C2017A00047:clause:12_37
Version: federal_register_of_legislation:C2017A00047
Segment Type: clause
Provision Reference: sch 12 cl 37
Character Range: 77820–79212

37  After subsection 41HD(1)
Insert:
 (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.