Skip to main content

Open Consultations

The TGA regularly consults with industry and stakeholders before making significant regulatory changes. Participating in consultations is one of the most effective ways for sponsors, manufacturers, and regulatory affairs professionals to influence regulatory outcomes.

All open consultations are published on the TGA's consultation hub — always check directly for the current list as status changes frequently.

👉 TGA Consultation hub — all open consultations

How to Find Open Medical Device Consultations​

On the TGA consultation hub:

  1. Go to consultations.tga.gov.au
  2. Filter by Medical devices in the product type filter
  3. Filter by Open in the status filter to see consultations currently accepting submissions

Submissions are typically accepted for 4–8 weeks. The TGA usually publishes a summary of feedback received after consultation closes.

Recent Notable Consultations​

Proposed Changes to Conformity Assessment Procedures (December 2025)​

The TGA consulted on proposed changes to Schedule 3 of the Therapeutic Goods (Medical Devices) Regulations 2002, (including EU MDR and FDA approaches) Implementation date to be confirmed. including:

  • Potential phasing out of Part 5 (Product Quality Assurance) procedures
  • Alignment with evolving international conformity assessment practices
  • Changes to requirements for specific device classes

Status: Closed — check TGA website for outcomes and implementation timeline.

👉 TGA consultation outcomes

UDI Implementation — Ongoing​

The TGA continues to consult on the implementation of Unique Device Identification (UDI) requirements across additional device classes. UDI requirements are being phased in progressively, starting with higher-risk classes.

👉 UDI consultations — TGA

How to Make an Effective Submission​

When responding to a TGA consultation:

  • Address the specific questions asked — the TGA structures consultations around specific proposals; address each directly
  • Use regulatory evidence — cite comparable regulatory frameworks (EU MDR, FDA) where relevant to support or challenge proposals
  • Be specific about impact — quantify the compliance burden where possible (cost, timeframes, affected products)
  • Coordinate with your association — MTAA and ARAS often coordinate industry submissions, which carry more weight than individual responses

Industry Associations​

Australian medical device industry associations participate actively in TGA consultations and can provide early notice of proposed changes:

AssociationFocusWebsite
MTAA — Medical Technology Association of AustraliaBroad medical device industrymtaa.org.au
ARAS — Australasian Regulatory Affairs SocietyRegulatory affairs professionalsaras.com.au
Pathology Technology Australia (PTA)IVD industrypathologytechnology.com.au

Discuss on GitHub​

Have a view on an open consultation? Share it with the RAPath community: