Commonwealth Consolidated Acts

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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 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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