Overview of the software reclassification reforms and an opportunity for stakeholders to ask questions about transitional arrangements for software based medical devices affected by the changes.
Background
Changes to the classification rules for software-based medical devices commenced on 25 February 2021.
All sponsors of software-based medical devices included in the Australian Register of Therapeutic Goods (ARTG) that notified us that their products need to be reclassified must:
submit an application for inclusion in the ARTG; OR
apply for a TGA conformity assessment certificate under the new classification rules before the transition deadline on 1 November 2024.
