Therapeutic Goods Act 1989

The regulations may set out requirements relating to the obligations of manufacturers of medical devices.

These requirements are to be known as the conformity assessment procedures.

The conformity assessment procedures, or any part of the conformity assessment procedures, may:

be limited in their application to one or more medical device classifications; or

apply differently to different medical device classifications, different kinds of medical devices or different manufacturers.

Without limiting subsection (1), the regulations may relate to all or any of the following:

application of quality management systems for the manufacture of medical devices;

certification of compliance with the essential principles, or the quality management systems for the manufacture of medical devices;

notification of, and assessment of, changes to a manufacturer’s product range, product design or quality management systems;

declarations to be made by manufacturers of medical devices that conformity assessment procedures have been applied to the devices;

marks to be affixed to medical devices indicating the application of the conformity assessment procedures to the devices;

monitoring and inspecting the design of medical devices or the manufacturing processes for medical devices;

monitoring the performance of medical devices;

corrective action required in relation to the design, manufacture, packaging, labelling and supply of medical devices;

keeping records of the manufacture of medical devices, the design of medical devices or the manufacturing processes for medical devices.