🇦🇺 Australian Market

AusUDID —
Australia UDI Support

We can assist you with all your AusUDID needs, from M2M and Bulk uploads to providing general advice on the requirements. We can help you with every aspect of your TGA AusUDID journey.

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Operated by

Therapeutic Goods Administration (TGA), Australia

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Went live

24 March 2025

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High-risk compliance

1 July 2026

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Standard

Aligns with IMDRF international standards

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Links to

Australian Register of Therapeutic Goods (ARTG)

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We cover

M2M, bulk uploads & AusUDID advisory services

Overview

What is AusUDID?

AusUDID is the Australian Unique Device Identification Database, managed by the TGA for medical devices in Australia. It is designed to boost patient safety by tracking medical devices.

AusUDID is a publicly accessible database that stores unique device identifiers (UDI-DIs) and related information for medical devices and in vitro diagnostic devices supplied in Australia. It links to the Australian Register of Therapeutic Goods (ARTG).

It contains data such as device identifiers, brand names, sizes, clinical characteristics, and related Patient Information Leaflets — but it does not store patient information or commercially confidential data.

Patients, consumers, healthcare professionals, and clinical quality registries can search and download information from AusUDID for free using criteria like UDI-DI, ARTG number, or GMDN code. Sponsors and manufacturers submit and maintain UDI data, with compliance phased in over five years, starting with high-risk devices.

Effective date

AusUDID went live on 24 March 2025 and aligns with international standards set by the International Medical Device Regulators Forum (IMDRF).

AusUDID Features

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Search & lookup

Search by UDI-DI, keyword (brand/manufacturer name), ARTG number, or GMDN code.

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Device details

Device identifiers, brand name, description, model/version, clinical characteristics, manufacturer details, ARTG inclusion, packaging, and Patient Information Leaflets.

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Change history

View the history of UDI record changes for any device.

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Download options

Single UDI records, search results, full database, or periodic updates (daily, weekly, monthly).

AusUDID Environments

Production — Public

Current data, accessible to healthcare professionals and consumers.

ausudid.tga.gov.au ↗

Pre-Production — Testing

For sponsors and manufacturers only. Requires a TGA Business Services (TBS) account.

ebs.tga.gov.au ↗
Compliance Timeline

AusUDID Key Dates vs. EUDAMED

Understanding both timelines helps organisations plan their global UDI compliance strategy.

System Key Date 2025 Key Date 2026 Notes
🇦🇺 AusUDID Live
24 March 2025: Went live
Upcoming
1 July 2026: Compliance for high-risk devices starts
Phased implementation over five years, starting with high-risk devices.
🇪🇺 EUDAMED Q3–Q4 2025: Formal publication of modules Upcoming
Q2–Q3 2026: Mandatory use of published modules begins
Gradual rollout, with full functionality targeted for 2027.

Medical Device UDI Compliance Start Dates

The UDI compliance start dates for each device class are outlined below.

AusUDID medical device UDI compliance start dates by device class

↔ Scroll to see full table on small screens

Our Services

How EirMed can help with AusUDID

We can give you as much assistance as you need. AusUDID, EUDAMED, and regulatory submissions are our business.

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M2M Integration

Machine-to-machine integration for automated AusUDID submissions, connecting your systems directly to the TGA portal.

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Bulk Uploads

High-volume device data uploads to AusUDID — we handle the full submission process on your behalf.

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Advisory Services

General advice on AusUDID requirements, compliance timelines, and what you need to do to meet your obligations.

Growing our coverage

We continue to grow — EUDAMED, GUDID, AusUDID, SwissDaMed, and more to come. Let our experts solve your regulatory submission challenges across every major jurisdiction.

🇪🇺 EUDAMED 🇦🇺 AusUDID 🇨🇭 SwissDaMed 🇺🇸 GUDID

Need help with AusUDID?

Contact us to see how our services can benefit you. We respond within 1 business day.