Commonwealth Consolidated Acts

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THERAPEUTIC GOODS ACT 1989 - SECT 41FDA

Basis of certification of conformity assessment procedures

  (1)   When certifying the matter referred to in paragraph   41FD(f), the applicant must also state that the certification of the matter is based:

  (a)   on a conformity assessment certificate that is in force; or

  (b)   on an Australian conformity assessment body certificate that is in force; or

  (c)   on an overseas regulator conformity assessment document that is in force.

  (2)   However, subsection   (1) does not apply if devices of the kind in question are class I medical devices (within the meaning of regulations made for the purposes of this Chapter).



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