Commonwealth Consolidated Acts

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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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