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THERAPEUTIC GOODS ACT 1989 - SECT 41DD Content of conformity assessment standards

THERAPEUTIC GOODS ACT 1989 - SECT 41DD

Content of conformity assessment standards

  (1)   Without limiting the scope of section   41DC, an order establishing a conformity assessment standard for a kind of medical device may be specified by reference to:

  (a)   procedures to be carried out under the quality management systems for the design, manufacture and final inspection of the devices; or

  (b)   a standard published by a standards organisation; or

  (c)   such other matters as the Minister thinks fit.

  (2)   For the purposes of paragraph   (1)(b), these are standards organisations:

  (a)   Standards Australia;

  (b)   the International Organisation for Standardization;

  (c)   the European Committee for Standardization;

  (d)   any other organisation declared by the Minister by notice published in the Gazette or on the Department's website.

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