Document ID: chunk:federal_register_of_legislation:C2024C00632:section:41dd
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 41DD
Character Range: 660550–661346

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.