Document ID: chunk:federal_register_of_legislation:C2024C00632:section:41fia
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 41FIA
Character Range: 717778–718714

41FIA  Certificates issued by Australian conformity assessment bodies
 (1) If:
 (a) a section 41FC application is made for a kind of medical device to be included in the Register; and
 (b) the application has been selected for audit; and
 (c) a person has obtained a certificate issued by an Australian conformity assessment body to the effect that the body is satisfied that an appropriate conformity assessment procedure has been applied to devices of that kind; and
 (d) the certificate has been given to the Secretary; and
 (e) if the conformity assessment body determination that relates to the body is limited as mentioned in paragraph 41EWA(4)(b)—the Secretary is satisfied that the certificate has been issued consistently with the determination;
the Secretary may have regard to the certificate in auditing the application.
 (2) This section does not, by implication, limit the matters to which the Secretary may have regard.