Australia TGA SaMD registration: what EU MDR holders need to know

The key fact most SaMD companies miss about TGA and EU MDR

Australia's Therapeutic Goods Administration (TGA) operates under the Therapeutic Goods Act 1989 and regulates medical devices under a classification framework that closely mirrors EU MDR. SaMD classification under TGA generally matches EU MDR classification — with one important caveat: for software with population health implications, TGA may classify at a higher risk level than MDR. A device that is Class IIa under MDR could in some circumstances be Class IIb in Australia.

But here is what matters most for companies with EU MDR certification: under the Therapeutic Goods (Medical Devices) Regulations 2002, a manufacturer that holds EU MDR 2017/745 certification by an EU Notified Body is specifically exempted from mandatory TGA audit requirements for their Australian applications. This dramatically reduces both timeline and cost compared to manufacturers without prior international approval.

TGA SaMD classification — how it maps to EU MDR

TGA uses four classification levels for medical devices: Class I, Class IIa, Class IIb, and Class III — the same structure as EU MDR. For SaMD, TGA classification generally follows the same risk-based logic as EU MDR Rule 11: software that provides information for therapeutic or diagnostic decisions in serious conditions classifies as IIa or higher; software for physiological monitoring classifies as IIa or lower.

The critical difference from EU MDR: TGA's software classification rules consider risk to both the individual patient AND to population health. Software that processes data at a population level — or whose failure could affect many patients simultaneously — may be classified at a higher level in Australia than the equivalent EU MDR class. Before finalising your TGA strategy, verify that your device's Australian classification matches your MDR classification. A mismatch does not disqualify you from the EU MDR reference pathway but does affect which conformity assessment procedures apply.

The ARTG inclusion process for EU MDR certified SaMD

Getting your SaMD included in the Australian Register of Therapeutic Goods (ARTG) requires the following steps:

1. Appoint an Australian Sponsor: All non-Australian manufacturers must appoint a licensed Australian Sponsor. The Sponsor is the entity that applies for and holds the ARTG entry. The Sponsor takes on post-market obligations in Australia including adverse event reporting, recalls, and correspondence with TGA. Your Sponsor can be a distributor, an independent regulatory consultant, or a dedicated regulatory sponsorship service.
2. Determine applicable conformity assessment pathway: For SaMD classified as Class IIa or above, conformity assessment evidence is required. EU MDR 2017/745 certification from an EU Notified Body qualifies as accepted overseas conformity assessment evidence, exempting you from mandatory TGA audit unless TGA specifically selects your application for audit review.
3. Prepare ARTG application documentation: The application through TGA's TBS (Therapeutic Goods Business Services) portal requires: Declaration of Conformity, clinical evidence summary, device description, risk management summary, post-market surveillance plan, labelling (including Australian-specific requirements), and your EU MDR or NB certificate as conformity evidence.
4. ARTG inclusion decision: For EU MDR certified Class IIa SaMD, TGA target assessment time is 30–60 business days. TGA may request additional information — respond within the specified timeframe to avoid timeline extension. Once included in the ARTG, your device receives an ARTG number which must appear on Australian labelling.

What TGA requires beyond EU MDR documentation

Your EU MDR technical file covers the core of what TGA needs, but several Australia-specific elements are required:

• Australian Declaration of Conformity: TGA requires a DoC referencing Australian therapeutic goods legislation — the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002 — in addition to your EU MDR DoC.
• Australian labelling requirements: ARTG number must appear on labelling once issued. Sponsor name and address must appear. English language is required. Some devices require Mandatory Standards compliance (TGA Mandatory Standards specify labelling requirements for specific device types).
• Post-market obligations under Australian law: Adverse event reporting to TGA, recall procedures compliant with Australian recall requirements, and ARTG entry maintenance (renewals and updates) are governed by Australian law, not EU MDR. Your QMS must include Australian post-market procedures.
• TGA cybersecurity expectations: TGA's August 2025 SaMD guidance aligns cybersecurity expectations with MDCG 2019-16 and FDA's cybersecurity framework. If your MDCG 2019-16-compliant cybersecurity documentation is current, minimal additional work is required for TGA.

Mandatory audit — when it applies despite EU MDR certification

While EU MDR certification generally exempts you from mandatory TGA audit, TGA retains the right to select any application for audit review. Two levels of audit exist: Level 1 (documentary audit) and Level 2 (full documentary and factory audit). TGA's target timeframes for audits are 30–60 business days, but audits can extend timelines significantly if deficiencies are found.

To minimise audit risk: ensure your EU MDR certificate covers exactly the device and intended use as described in your Australian application, your clinical evidence is current and reflects the Australian classification level for your device, and your QMS covers Australian-specific post-market obligations.

MDSAP — the optional audit efficiency multiplier

Australia participates in the Medical Device Single Audit Program (MDSAP). An MDSAP audit conducted by a recognised MDSAP Auditing Organisation satisfies QMS audit requirements for Australia (TGA), USA (FDA), Canada (Health Canada), Japan (PMDA/MHLW), and Brazil (ANVISA) in a single audit. For SaMD companies targeting multiple markets, MDSAP can significantly reduce ongoing audit burden. ISO 13485 certification from an MDSAP-authorised auditing body is the foundation.