Upcoming Changes
Planning ahead for regulatory changes is essential for sponsors and manufacturers. This page tracks announced and anticipated changes to Australian medical device regulation.
Always verify upcoming change dates and details on the TGA website before making compliance plans based on this page.
Now in Effect — Recently Commenced
21 March 2026 — Mandatory Healthcare Facility Adverse Event Reporting ✅ Now in Effect
What changed: From 21 March 2026, healthcare facilities must mandatorily report adverse events involving high-risk medical devices to the TGA. High-risk devices include Class III, AIMD (now Class III), and IVD Class 4.
Reporting requirements for facilities:
- Death or serious deterioration: within 10 calendar days
- Reports submitted via the ASDER system
For sponsors: Hospitals may now report adverse events to the TGA independently and before contacting the sponsor. Vigilance processes should account for this — sponsors should not assume they will always be the first to notify the TGA.
👉 Healthcare facility reporting — TGA
Confirmed — With Known Dates
1 July 2026 — UDI Mandatory for Class IIb and Class III Devices
What changes: Mandatory compliance with the Unique Device Identification (UDI) system begins for Class IIb and Class III medical devices (including implantable devices). Manufacturers must use barcodes on all packaging and labelling and submit UDI data to the TGA's AusUDID database.
UDI information will be integrated into hospital systems and patient records including MyHealth Record, enabling tracking and tracing of implanted devices.
Who must prepare now:
- Manufacturers of Class IIb and Class III devices — update labelling and packaging to include UDI barcodes before July 2026
- Sponsors — ensure manufacturer compliance and update ARTG entries as required
- Healthcare facilities — prepare hospital systems for UDI data capture
Action required: If you have not yet commenced UDI implementation for Class IIb and III devices, this deadline is imminent.
1 July 2026 — Animal Origin Device Reclassification Deadline
What changes: Sponsors of ARTG entries affected by the July 2024 changes to classification rule 5.5 (devices containing non-viable tissues or cells of animal origin) must submit reclassification applications before 1 July 2026. They can continue to supply under existing ARTG entries unless the reclassification application is unsuccessful.
Who is affected: Sponsors of medical devices containing non-viable animal tissues or cells (other than hair, wool, sintered hydroxyapatite, or tallow derivatives). Note: devices containing substances of microbial or recombinant origin are no longer affected by rule 5.5.
👉 Medical device regulation changes — TGA
1 April 2028 — Expanded Mandatory Healthcare Facility Reporting
What changes: Mandatory reporting expands to include:
- Adverse events involving medium-risk devices (Class IIa, IIb, IVD Class 2, IVD Class 3)
- Near-miss events for high-risk devices
Who must prepare: Sponsors of medium-risk devices not yet in scope for 2026 mandatory reporting.
1 April 2030 — Further Expansion
What changes: Mandatory reporting further expands to additional event types and device classes. Check TGA guidance as 2030 approaches for specifics.
Confirmed — Date Pending
Conformity Assessment Procedure Changes
Following the December 2025 consultation, the TGA is expected to implement changes to Schedule 3 conformity assessment procedures, potentially including phasing out of Part 5 (Product Quality Assurance) procedures. Implementation date to be confirmed.
Who is affected: Manufacturers currently relying on Schedule 3 Part 5 procedures.
Proposed Changes to Clinical Trial Oversight
The TGA has proposed increased oversight for clinical trials of high-risk medical devices. Key proposals include:
- Requiring CTA (Clinical Trial Approval) — rather than CTN — for novel permanently-implantable devices that have not previously been used in people
- Including all medical device clinical trials in the GCP Inspection Program
These proposals are subject to consultation. If implemented, they would affect a small number of trials (estimated less than 10% of current medical device trials) but would significantly increase regulatory burden for first-in-human implantable device trials.
Ongoing — Progressive Rollout
UDI Implementation (Beyond July 2026)
After the July 2026 deadline for Class IIb and III devices, UDI requirements will roll out progressively to lower-risk device classes. Check the TGA UDI hub for the current implementation timeline.
EU MDR Transition — Ongoing Impact on Australia
EU MDD certificates are progressively expiring and being replaced by EU MDR certificates. Class III applications still relying on MDD certificates are subject to mandatory audit. Sponsors should work with manufacturers to plan MDR transition timelines.
👉 EU MDR transition guidance — TGA
How to Stay Ahead
👉 TGA email subscription 👉 TGA consultation hub 🔔 RAPath AU — upcoming changes issues