Changes to the classification of active implantable medical devices (AIMDs) and their accessories: The proposal would result in all AIMDs, their accessories, active devices intended to control, monitor or influence the performance of an AIMD and software that drives or influences the use of an AIMD to be classified as Class III. The proposal would not introduce any new regulatory requirements for sponsors of AIMDs as these products already follow the same conformity assessment procedure as for Class III devices. TGA has merely proposed changing the terminology of their classification from "Class AIMD" at present to Class III to harmonize the Australian device regulations with the EU and more broadly internationally. Changes have been proposed to the regulation of AIMD accessories – so that all of these are categorized as Class III. While implantable accessories are already classified as Class III, non-implantable accessories are at present classified as Class I, Class IIa or Class III depending on the intended purpose of the device. Devices affected by the proposed reclassification include pacemaker system analyzers, interface software and cochlear implant system connectors.

Australia Reviews Device Classification Rules To Align With EU

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