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Recent Regulatory Changes

This page summarises significant regulatory changes affecting Australian medical device regulation from 2024 to 2026. Changes are listed from most recent to oldest. For the full legislative history, see Recent Amendments.

2026​

May 2026 — New TGA AI and SaMD Guidance Published​

The page header states '2026' and 'May 2026 — New TGA AI and SaMD Guidance Published' but then states 'In guidance' — verify whether the actual publication date was February or May 2026, as these conflict. If the was published in February, the section header should read 'February 2026' not 'May 2026'. February 2026, the TGA published updated guidance specifically addressing how artificial intelligence (AI) is regulated within the existing Software as a Medical Device (SaMD) framework. Two complementary guidance pages clarify:

  • AI medical devices are regulated within the established SaMD framework — there is no separate AI-specific regime
  • Classification remains based on intended purpose and clinical context, not the presence of AI features
  • AI does not reduce or alter Essential Principles obligations — lifecycle management, change control, and clinical evidence requirements apply in full
  • The TGA confirmed that AI features do not automatically increase a device's risk class

Who is affected: Manufacturers and sponsors of software-based medical devices incorporating AI or machine learning components.

👉 AI and medical device software regulation — TGA

January 2026 — TGA Compliance Principles 2026–2027 Released​

The TGA released its Compliance Principles 2026–2027, setting out its strategic approach to monitoring and enforcement for the next two years. For medical devices, the TGA has identified the following as priority focus areas — meaning increased compliance scrutiny:

  • Direct-to-consumer (DTC) IVD kits — including at-home tests supplied online
  • Fetal dopplers — particularly those sold directly to consumers without clinical supervision
  • Software as a Medical Device (SaMD) — ongoing focus following the November 2024 ARTG inclusion deadline
  • Devices used in cosmetic procedures — classification compliance and Essential Principles evidence

Sponsors of devices in these categories should review their ARTG entries and post-market surveillance systems. The TGA may issue formal Post Market Reviews (PMRs) under Section 41JA of the Act, requiring demonstration of compliance within 20 business days.

Who is affected: Sponsors and manufacturers of DTC IVDs, fetal dopplers, SaMD, and cosmetic procedure devices.

👉 TGA Compliance Principles 2026–2027

2025​

March 2025 — PRAC Replaces URPTG (5 March 2025)​

The Procedure for Recalls, Product Alerts and Product Corrections (PRAC) replaced the Uniform Recall Procedure for Therapeutic Goods (URPTG) from 5 March 2025.

Key changes under PRAC:

  • Eight action categories reduced to four market action types: Recall, Product Alert, Product Correction, Quarantine
  • Procedural steps reduced from 10 to 5
  • The Database for Recalls, Product Alerts and Product Corrections (DRAC) replaced the former SARA database
  • Unified terminology — "market actions" replaces the former recall/non-recall distinction

Who is affected: All Australian medical device sponsors. Recall SOPs and written sponsor-manufacturer agreements should be reviewed and updated.

👉 PRAC — TGA

March 2025 — Healthcare Facility Adverse Event Reporting Commenced​

Supporting regulations to Part 4-8A of the Therapeutic Goods Act 1989 came into force from 21 March 2025, commencing staged implementation of mandatory adverse event reporting by healthcare facilities.

Implementation timeline:

  • 21 March 2025 – 20 March 2026: Voluntary reporting period via the ASDER system ✅ Completed
  • 21 March 2026: Mandatory reporting for high-risk devices (Class III, AIMD, IVD Class 4) — Now in effect
  • 1 April 2028: Expanded mandatory reporting for medium-risk devices and near-miss events
  • 1 April 2030: Further expansion

Who is affected: All Australian public, private, and day hospitals. Sponsors should ensure vigilance processes account for hospital-initiated reports.

👉 Healthcare facility reporting — TGA

2024​

November 2024 — Software Classification Rules Fully Effective​

From 1 November 2024, the grace period for software as a medical device (SaMD) ended. All software meeting the medical device definition must be included in the ARTG or covered by an exemption.

Updated classification rules apply — software is classified based on the potential severity of harm from an incorrect output:

  • Death or severe deterioration / high public health risk → Class III
  • Serious condition / moderate public health risk → Class IIb
  • Non-serious condition / no public health risk → Class IIa
  • One class lower applies where software only provides a recommendation to a health professional

👉 Software and AI — TGA

November 2024 — AIMD Reclassification Deadline​

All existing AIMD ARTG entries were required to have transitioned to Class III applications by 1 November 2024. AIMD entries not reclassified by this date must cease supply. New applications for active implantable devices are now submitted as Class III.

👉 Reclassifying AIMDs — TGA

November 2024 — Patient Implant Card Requirements Mandatory​

Patient implant card requirements became mandatory for all implantable medical devices supplied in Australia. Manufacturers and sponsors must ensure patient implant cards accompany all implantable devices, and that healthcare facilities provide them to patients at the time of implantation.

👉 Patient implant cards — TGA

July 2024 — Regulation 5.3 Amendment​

From 1 July 2024, updated manufacturer evidence requirements changed the ARTG application landscape:

  • Mandatory audit now applies to Class III applications supported by EU MDD certificates or US 510(k) clearance
  • EU MDR certificates from notified bodies with current designations receive more favourable treatment
  • Updated IVD evidence requirements reflecting EU IVDR transition progress

👉 Use of overseas regulator evidence — TGA (PDF)

July 2024 — Animal, Microbial, and Recombinant Origin Devices​

From 1 July 2024, new classification and conformity assessment requirements apply to medical devices incorporating substances of animal, microbial, or recombinant origin. Note that from 1 July 2024, the amended rule 5.5 applies only to devices containing non-viable tissues or cells of animal origin — it no longer applies to devices containing substances of microbial or recombinant origin. Sponsors of affected ARTG entries must submit reclassification applications before 1 July 2026.

👉 Animal/microbial/recombinant origin — TGA

Stay Current​

This page requires substantial completion. Based on context from other pages, it should include full descriptions of: November 2024 SaMD changes, Patient implant card requirements, AIMD reclassification, and any other 2024–2025 changes referenced in the Reforms Tracker and Upcoming Changes pages.