Commonwealth Consolidated Acts Commonwealth Consolidated Acts(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.