Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 25B

             (1)  If:

                     (a)  an application is made in accordance with section 23 for the registration 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 that would require evaluation under subsection 25(1) if that subsection applied in relation to the device;

the Secretary must register the device 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 on the application within 28 days of the making of the decision. If the Secretary decides not to register the device, the notice must contain the reasons for that decision.

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

                     (a)  include the device in the Register; and

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

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