Commonwealth Consolidated Acts Commonwealth Consolidated ActsThe requirements for medical devices are:
(a) essential principles (that are about the safety and performance characteristics of medical devices); and
(b) conformity assessment procedures (that are mainly about the application of quality management systems) or requirements comparable to conformity assessment procedures.
Note: Medical device standards may be made under Division 2 of
Part 4 - 2, and conformity assessment standards may be made under
Division 2 of Part 4 - 3, but they are not requirements.