Commonwealth Consolidated Acts

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THERAPEUTIC GOODS ACT 1989 - SECT 41EK

Conditions imposed when conformity assessment certificates are issued

    If the Secretary issues a conformity assessment certificate in respect of a manufacturer, the Secretary may, in writing, impose conditions on the certificate in respect of:

  (a)   one or more kinds of medical devices covered by the certificate; or

  (b)   the manufacturer's quality management system.

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