Commonwealth Consolidated Acts

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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.

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