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THERAPEUTIC GOODS ACT 1989 - SECT 41BA Requirements for medical devices (Parts 4 - 2 and 4 - 3)

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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