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THERAPEUTIC GOODS ACT 1989 - SECT 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 devices of that kind comply with the essential principles; and

                     (d)  the certificate was issued under a contract between the person and the body; and

                     (e)  the certificate has been given to the Secretary;

then, in auditing the application, the Secretary may have regard to the certificate.

             (2)  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 was issued under a contract between the person and the body; and

                     (e)  the certificate has been given to the Secretary;

then, in auditing the application, the Secretary may have regard to the certificate.

             (3)  If a conformity assessment body determination that relates to an Australian conformity assessment body is limited to one or more specified kinds of medical devices, subsection (1) does not apply to a certificate issued by the body unless the certificate relates to one of those kinds of medical devices.

             (4)  If a conformity assessment body determination that relates to an Australian conformity assessment body is limited to one or more specified kinds of conformity assessment procedures, subsection (2) does not apply to a certificate issued by the body unless the certificate relates to one of those kinds of conformity assessment procedures.

             (5)  This section does not, by implication, limit the matters to which the Secretary may have regard.



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