Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 26AA

             (1)  If:

                     (a)  an application is made in accordance with section 23 for the listing of a therapeutic device in relation to a person; and

                     (b)  the applicant gives to the Secretary an EC/EFTA attestation of conformity as to the matters specified in paragraphs 26(1)(c) to (m) in relation to the device;

the Secretary must list the device in relation to the person unless the Secretary considers that the device may compromise the health or safety of users.

             (2)  The Secretary must notify the applicant in writing of his or her decision within 28 days of the making of the decision. If the Secretary decides not to list the device, the notice must contain the reasons for that decision.

             (3)  If the Secretary decides to list the device, the Secretary must:

                     (a)  include the device in the Register; and

                     (b)  give to the applicant a certificate of listing.

             (4)  The listing of the device commences on the day specified for the purpose in the certificate of listing.