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Reclassification Updates

Overview​

Australia's classification rules have undergone significant changes in recent years as part of broader regulatory harmonisation with the EU MDR/IVDR and global IMDRF standards. Manufacturers and sponsors with existing ARTG entries should review their device classifications regularly to ensure continued compliance. This page summarises the key reclassification changes.

AIMD → Class III (Completed: 1 November 2024)​

Active implantable medical devices (AIMDs) — previously the highest-risk class — have been merged into Class III. From 25 November 2021, all new applications for devices that would previously have been AIMD are submitted as Class III. Sponsors of existing AIMD entries were required to notify the TGA and submit Class III applications by 1 November 2024.

Current status: AIMD as a separate classification category is effectively closed for new applications. Existing AIMD entries that were not reclassified by 1 November 2024 must cease supply.

👉 Reclassifying AIMDs — TGA

Software as a Medical Device (Completed: 1 November 2024)​

Updated classification rules for software-based medical devices came into full effect on 1 November 2024, ending the grace period that had allowed some software to remain on the market without ARTG inclusion. New software classification rules apply based on the severity of harm from incorrect output.

Current status: All SaMD that meets the medical device definition must be included in the ARTG or covered by a specific exemption.

👉 Software and AI — TGA

Personalised Medical Devices (2019 onwards)​

Regulatory changes progressively introduced new rules for personalised medical devices — including patient-matched, custom-made, and other non-standard devices. These changes clarified classification and conformity assessment requirements for 3D-printed and other personalised devices.

👉 Personalised medical devices — TGA guidance

IVD Reclassification (Ongoing — EU IVDR alignment)​

The TGA has been progressively aligning IVD classification rules and manufacturer evidence requirements with the EU IVDR (Regulation 2017/746). This has particularly affected which certificates from overseas assessment bodies are accepted as manufacturer evidence for IVD applications. The TGA continues to update its acceptance of EU IVDR certificates as EU notified bodies complete IVD device certifications.

Key change (1 July 2024): Updated Regulation 5.3 changed the manufacturer evidence requirements for several IVD classes. Check current TGA guidance for the specific evidence types accepted.

Proposed Changes — Watch This Space​

The TGA regularly consults on proposed regulatory changes. Key areas under consideration include:

  • Alignment of Essential Principles with EU MDR/IVDR General Safety and Performance Requirements (GSPRs)
  • Proposed changes to conformity assessment procedures (consultation December 2025)
  • Ongoing UDI (Unique Device Identification) rollout

Subscribe to TGA updates to receive notifications of regulatory changes:

👉 TGA subscription service

Official Sources​