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THERAPEUTIC GOODS ACT 1989 - SECT 41FKA

Medical devices (priority applicant) determinations

             (1)  The regulations may make provision for and in relation to empowering the Secretary to make medical devices (priority applicant) determinations.

             (2)  A medical devices (priority applicant) determination is a determination that, for the purposes of this Act, a specified person is a priority applicant in relation to any section 41FC application that may be made by the person for the inclusion in the Register of a medical device of a kind specified in the determination.

             (3)  The regulations may make provision for and in relation to the following matters:

                     (a)  applications for medical devices (priority applicant) determinations;

                     (b)  the approval by the Secretary of a form for such an application;

                     (c)  information that must accompany such an application;

                     (d)  the application fee for such an application.

             (4)  The regulations may make provision for and in relation to the following matters:

                     (a)  empowering the Secretary to revoke a medical devices (priority applicant) determination;

                     (b)  the consequences of the revocation of a medical devices (priority applicant) determination.

             (5)  Subsections (3) and (4) do not limit subsection (1).

             (6)  The regulations may make provision for and in relation to the priority to be given by the Secretary to consideration of a section 41FC application where the applicant is a priority applicant.

             (7)  The regulations may provide that, if:

                     (a)  a person is a priority applicant in relation to a section 41FC application made by the person; and

                     (b)  a decision is made on the application;

a statement setting out the decision may be published on the Department's website.

             (8)  The express references in this section to the Secretary do not, by implication, prevent the regulations from empowering the Secretary to delegate any or all of the Secretary's functions or powers under regulations made for the purposes of this section.

             (9)  If a medical devices (priority applicant) determination is in force under the regulations, the determination may be published on the Department's website.

           (10)  A medical devices (priority applicant) determination made under the regulations is not a legislative instrument.

           (11)  Subsection 33(3AB) of the Acts Interpretation Act 1901 does not apply to the specification of a person in a medical devices (priority applicant) determination.

Note:          Subsection 33(3AB) of the Acts Interpretation Act 1901 deals with specification by class.



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