Recent Amendments
Overview
Australian medical device legislation has undergone significant reform since 2020, with a series of amendments to the Therapeutic Goods Act 1989 and the MD Regulations implementing new regulatory requirements for software, IVDs, AIMDs, conformity assessment, adverse event reporting, and recalls. This page summarises the most significant changes chronologically.
2020 — Software and Specified Articles
Therapeutic Goods (Medical Devices — Specified Articles) Instrument 2020 Clarified the regulatory status of specific articles as medical devices, including certain software products. This instrument updated the regulatory definition to explicitly address emerging technology categories.
2021 — AIMD Reclassification and Overseas Evidence Expansion
November 2021 — AIMD → Class III reclassification Active implantable medical devices (AIMDs) were reclassified under the MD Regulations. From 25 November 2021:
- New applications for devices previously classified as AIMD must be submitted as Class III
- Existing AIMD ARTG entries could continue under transitional arrangements until 1 November 2024
- All AIMD entries not reclassified by 1 November 2024 were required to cease supply
July 2021 — EU IVDR certificates accepted The TGA updated Regulation 5.3 to accept certificates issued by EU notified bodies under the EU In Vitro Diagnostic Regulation (IVDR 2017/746) as manufacturer evidence for IVD applications. This supported the EU's transition from IVDD to IVDR.
2022 — Australian Conformity Assessment Bodies (CABs)
2022 — CAB framework operational Australian-based Conformity Assessment Bodies (CABs) became able to issue conformity assessment certificates for medical devices recognised by the TGA. This created a new domestic pathway for manufacturers, complementing the TGA's own certification and overseas regulator evidence pathways.
2023 — Healthcare Facility Reporting Mandate
March 2023 — Therapeutic Goods Amendment (2022 Measures No. 1) Act 2023 Parliament amended the Therapeutic Goods Act 1989 to require all Australian public, private, and day hospitals to report medical device adverse events to the TGA. Part 4-8A was inserted into the Act. Implementation was deferred to allow systems to be developed.
2024 — Regulation 5.3 and Software Classification
1 July 2024 — Regulation 5.3 amendment Significant changes to the manufacturer evidence requirements for ARTG applications:
- Mandatory audit criteria updated — Class III applications supported by EU MDD certificates or US 510(k) submissions now subject to mandatory audit
- EU MDR certificates (without current notified body designation) subject to enhanced scrutiny
- Updated IVD evidence requirements reflecting EU IVDR transition progress
1 November 2024 — Software classification rules fully effective The grace period for software as a medical device (SaMD) ended. From this date:
- All software meeting the medical device definition must be included in the ARTG or covered by a specific exemption
- New classification rules for software based on harm severity apply in full
- AIMD reclassification deadline — all existing AIMD ARTG entries must have transitioned to Class III or ceased supply
2025 — Healthcare Facility Adverse Event Reporting
5 March 2025 — MD Regulations amended + PRAC implemented Two major changes simultaneously:
1. Healthcare facility adverse event reporting commenced Supporting regulations to Part 4-8A of the Act came into force. A 12-month voluntary reporting period commenced from 21 March 2025. From 21 March 2026, mandatory reporting by healthcare facilities begins for adverse events involving high-risk devices (Class III, AIMD, IVD Class 4).
2. PRAC replaced URPTG The Procedure for Recalls, Product Alerts and Product Corrections (PRAC) replaced the Uniform Recall Procedure for Therapeutic Goods (URPTG). The PRAC simplifies recall terminology from 8 categories to 4 market action types and reduces the procedural steps from 10 to 5.
Upcoming Changes — Watch This Space
From 21 March 2026 Healthcare facility mandatory reporting becomes enforceable for high-risk medical devices.
From 1 April 2028 Healthcare facility mandatory reporting expands to medium-risk devices and near-miss events.
Proposed conformity assessment changes (consulted December 2025) The TGA consulted on proposed changes to Schedule 3 conformity assessment procedures, including potential phasing out of Part 5 (Product Quality Assurance) procedures. Check TGA consultation outcomes for the current status.
Staying Up to Date
The TGA publishes regulatory changes through:
- TGA website news — tga.gov.au/news
- TGA subscription service — email alerts for regulatory updates
- Consultation hub — consultations.tga.gov.au
- legislation.gov.au — for commencement of registered amendments