REGULATORY ALERT – AUSTRALIA

AusUDID Compliance Service
for Class IIb & III Medical Devices

Fixed-fee UDI submissions managed end-to-end — from ARTG audit through to confirmed database linking. No hourly billing surprises. Response within 1 business day.

View pricing →
AusUDID Guide →

MANDATORY DEADLINE

1 July 2026

PRICING FROM

AUD$950

RESPONSE TIME

1 business day

BILLING MODEL

Fixed-fee service

Who needs to act

Is Your Device Affected?

The 1 July 2026 deadline applies to manufacturers of higher-risk medical devices. If you fall into any of the categories below, you need to submit UDI records to AusUDID before that date

Class III Medical Devices

Implantable devices, orthopaedic systems, cardiac devices, neurosurgical implants, and other high-risk devices.

Class IIb Medical Devices

Diagnostic imaging, surgical instruments, infusion devices, wound care products, and medium-to-high risk devices.

Overseas Manufacturers

If your products are supplied in Australia via an Australian Sponsor, your UDI data must be submitted, even if you already comply with EUDAMED or GUDID.

OUR SERVICE

What Practical RA Does For You

We manage the entire AusUDID submission process — from reviewing your ARTG entries to confirming your records are live in the database.

1

ARTG Audit & Scoping

We review your current ARTG entries to confirm which devices require AusUDID submissions, identify any classification considerations, and confirm the number of UDI-DI records required. A fixed-fee quote is issued at this stage.

2

UDI-DI Verification & Issuing Agency Confirmation

We confirm your existing UDI codes (GS1, HIBCC, or ICCBBA) are recognised by the TGA, or advise on obtaining UDI-DI codes if not yet assigned. We align your UDI data with AusUDID Data Dictionary requirements.

3

Data Preparation & Validation

We structure all mandatory data fields — device descriptions, classification, manufacturer details, packaging levels, ARTG entry numbers, and clinical characteristics — ready for submission. All data is validated against TGA requirements before submission.

4

AusUDID Submission & ARTG Linking

We submit your UDI-DI records through the TGA’s AusUDID portal and confirm each record is correctly linked to your ARTG entries. Any TGA queries are handled directly by our team.

5

Confirmation & Compliance Record

You receive written confirmation of all submitted records, a compliance summary, and guidance on ongoing obligations — including UDI-PI labelling requirements and future direct marking deadlines.

key dates

Compliance Deadlines at a Glance

Deadlines vary by device class and whether your device relies on an EU MDD transitional certificate. Confirm which applies to your product during scoping.

DEVICE CLASS

UDI CARRIER ON LABEL

SUBMIT UDI-DI TO AUSUDID

Direct Marking (reusable)

Class III (standard)

1 Jul 2026

1 Jul 2026

1 Jan 2028

Class IIb (standard)

1 Jul 2026

1 Jul 2026

1 Jan 2029

Class III (EU MDD transitional)

1 Jan 2028

1 Jan 2028

1 Jan 2028

Class IIb implantable (EU MDD)

1 Jan 2028

1 Jan 2028

N/A

Class IIb non-implantable (EU MDD)

1 Jan 2028

1 Jan 2028

1 Jan 2029

Note: Devices manufactured and labelled before the deadline but still under sponsor control after 1 July 2029 must be relabelled. Plan stock accordingly. Full compliance guide →

Transparent Pricing. No Surprises.

1 – 10 UDI’s

AUD $950

✦

Priority Submission

✦

ARTG entry review

✦

UDI-DI verification

✦

AusUDID portal submission

Get Started →

11 – 50 UDI’s

AUD $1,850

✦

ARTG entry review

✦

UDI-DI verification

✦

Data preparation & validation

✦

AusUDID portal submission

✦

Priority submission

Get Started →

51 – 100 UDI’s

AUD $2,950

✦

ARTG entry review

✦

UDI-DI verification

✦

Data preparation & validation

✦

AusUDID portal submission

✦

Custom quoting for portfolios of 100+

Get Started →

Not sure how many UDI records you need? The number of required UDI-DI submissions depends on your ARTG entries and device variants — not your total SKU count. Contact us for a free ARTG audit and we will confirm the exact number before any commitment.

Why choose us

A Boutique Firm. Local TGA Experience.

Unlike large multinational regulatory consultancies, Practical RA operates as a specialist boutique with senior-led work, direct access to our team, and active TGA relationships built over years.

Australian-based team

Our Melbourne office engages directly with the TGA. We’re not routing your matter through an overseas hub so your submission is managed locally.

Fixed-fee, no surprises

Every engagement is quoted at a fixed fee after scoping. You know the cost before you commit. No timesheets, no scope creep invoices.

1 business day response

All enquiries are responded to within one business day. Urgent deadline-driven engagements are prioritised accordingly.

End-to-end managed

We handle everything from initial ARTG audit through to live AusUDID records. You don’t need to learn the TGA portal or data dictionary.


Complements your sponsor

Already have an Australian Sponsor? We work alongside existing sponsor arrangements. AusUDID compliance is a separate obligation: we specialise in it.

EU & FDA alignment

Already compliant with EUDAMED or FDA GUDID? We map your existing UDI data to AusUDID requirements, saving time and avoiding duplication.

Frequently Asked Questions

common questions

The Australian Sponsor (the entity listed on the ARTG) holds the compliance obligation. Overseas manufacturers can must upload their UDI-DI entries, but submissions must be made by or on behalf of the Sponsor. If you are an overseas manufacturer without a Sponsor, you will need one before you can comply. Practical RA can assist with both Sponsor appointment and AusUDID submissions.

Yes. AusUDID is a separate database with its own submission requirements. However, if your devices carry GS1, HIBCC, or ICCBBA-issued UDI codes (all TGA-recognised issuing agencies), and your UDI data is already structured, the submission process is significantly streamlined. We map your existing UDI records to AusUDID Data Dictionary requirements, avoiding duplication of effort.

If your device is supplied in Australia under an EU MDD certificate covered by EU Transition Regulation 2023/607, the extended deadlines (January 2028 or 2029) apply. This depends on the certification basis of your current ARTG listing. We confirm this during the initial ARTG audit at no additional charge.

Each unique device model requires a separate UDI-DI record. This doesn’t necessarily mean one per ARTG entry i.e. multiple device variants can share an ARTG entry, or a single model can span multiple entries. The exact number is confirmed during scoping, and your fixed-fee quote is based on the actual UDI-DI count, not your ARTG entry count.

Non-compliance with mandatory AusUDID obligations may constitute a breach of the Therapeutic Goods Act. The TGA has powers to impose civil penalties, cancel ARTG entries, or issue compliance notices. Beyond regulatory risk, non-compliant devices cannot legally be supplied in Australia after the mandatory date. Acting now, while the deadline is still achievable, is significantly less costly than remediation after the fact.

For most portfolios, we target 2–3 weeks from engagement to confirmed submissions. Larger portfolios (50+ UDIs) are typically scheduled over 3-5 weeks with phased submissions. We recommend starting immediately; submissions can be made now, with voluntary compliance available since March 2025. Leaving it to Q2 2026 creates unnecessary risk if TGA queries arise.

Yes. Practical RA provides Australian Sponsor services for overseas manufacturers. We can act as your Sponsor and manage your AusUDID obligations under a combined engagement. Learn more about our Australian Sponsor service →

Why choose us

Request a Free ARTG Audit & Quote

Tell us about your device portfolio and we’ll confirm the number of UDI-DI records required, your applicable deadline, and your fixed-fee quote, at no cost and with no obligation.

✓ Response within 1 business day · All enquiries treated confidentially · No commitment required

✉ Or contact Tara directly: tara@practicalra.com

AusUDID Contact Form