Therapeutic Goods Act 1989

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:

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

a standard published by a standards organisation; or

such other matters as the Minister thinks fit.

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

Standards Australia;

the International Organisation for Standardization;

the European Committee for Standardization;

any other organisation declared by the Minister by notice published in the Gazette or on the Department’s website.