Commonwealth Consolidated Acts

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THERAPEUTIC GOODS ACT 1989 - SECT 41EWB

Content of Australian conformity assessment body certificates

             (1)  An Australian conformity assessment body certificate that is issued to a manufacturer of medical devices must specify whether it covers:

                     (a)  all medical devices manufactured by the manufacturer; or

                     (b)  only specified medical devices manufactured by the manufacturer.

             (2)  An Australian conformity assessment body certificate must contain any other information prescribed by the regulations for the purposes of this subsection.

             (3)  An Australian conformity assessment body certificate may be subject to conditions specified in the certificate.



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