Therapeutic Goods Act 1989

The regulations may make provision for and in relation to empowering the Secretary to make conformity assessment (priority applicant) determinations.

A conformity assessment (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 41EB application that may be made by the person for a conformity assessment certificate in relation to medical devices of a kind specified in the determination.

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

applications for conformity assessment (priority applicant) determinations;

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

information that must accompany such an application;

the application fee for such an application;

empowering the Secretary to give the applicant a written notice requiring the applicant to give to the Secretary specified information or documents in connection with the application within a specified period (which must be at least 10 working days after the notice is given to the applicant).

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

empowering the Secretary to revoke a conformity assessment (priority applicant) determination;

the consequences of the revocation of a conformity assessment (priority applicant) determination.

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

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

The regulations may provide that, if:

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

a decision is made on the application;

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.

If a conformity assessment (priority applicant) determination is in force under the regulations, the determination may be published on the Department’s website.

A conformity assessment (priority applicant) determination made under the regulations is not a legislative instrument.

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

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