Commonwealth Consolidated Acts

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THERAPEUTIC GOODS ACT 1989 - SECT 41BA

Requirements for medical devices (Parts 4-2 and 4-3)

                   The 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.



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