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THERAPEUTIC GOODS ACT 1989 - SECT 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 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 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 .

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 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), paragraph (1A)(c), (d), (e), (f), (g) or (h), 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), (1A) or (2) is not a legislative instrument.

   



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