Commonwealth Consolidated Acts

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THERAPEUTIC GOODS ACT 1989 - SECT 41CC

Content of medical device standards

  (1)   Without limiting the scope of section   41CB, an order establishing a medical device standard for kinds of medical devices may be specified by reference to:

  (a)   the safety or performance characteristics of the devices; or

  (b)   a monograph in the British Pharmacopoeia, the European Pharmacopoeia or the United States Pharmacopeia - National Formulary; or

  (c)   a monograph in a publication approved by the Minister for the purposes of this subsection; or

  (d)   such a monograph as modified in a manner specified in the order; or

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

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

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

  (a)   Standards Australia;

  (b)   the International Organisation for Standardization;

  (c)   the International Electrotechnical Commission;

  (d)   the European Committee for Standardization;

  (e)   the European Committee for Electrotechnical Standardization;

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


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