Australia regulates medical devices through the Therapeutic Goods Administration (TGA) under the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002. To sell legally, your device must be included in the Australian Register of Therapeutic Goods (ARTG), sponsored by an Australian entity, and supported by conformity assessment evidence. If you already hold a CE certificate under the EU MDR and a valid ISO 13485 certificate, Australia is one of the cheapest and fastest markets to add.

By Tibor Zechmeister and Felix Lenhard.

TL;DR

  • Australia's regulator is the TGA, operating under the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002 .
  • Every medical device must be included in the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia.
  • A non-Australian manufacturer must appoint an Australian Sponsor who holds the ARTG entry and carries post-market obligations.
  • Australia's classification rules are closely aligned with EU MDR rules, which makes the technical dossier you already built for CE marking largely reusable.
  • MDSAP certification is accepted by the TGA for QMS evidence and can significantly shorten the conformity assessment path.
  • Common surprises include English-language labelling requirements, Australian sponsor name on the label, UDI rules that are still being phased in, and TGA application audits for higher-risk classes.

Why this matters for EU MedTech founders

Australia is the market most EU MedTech founders underestimate. It is English-speaking, affluent, has a public health system that reimburses devices, and — critically — its regulatory framework is one of the closest in the world to EU MDR. For a startup that just burned two years getting CE marked, Australia is often the lowest-friction second market to add, cheaper and faster than the US.

The trap is thinking "close to EU" means "same as EU". It is not. The TGA runs its own conformity assessment system. It has its own classification tables, its own sponsor model, its own labelling expectations, and its own post-market reporting rules. A founder who copies their EU dossier into the ARTG application without a mapping step will lose months.

This post walks through what the TGA actually requires, how your existing EU evidence translates, and where the real surprises hide.

What the Australian framework actually says

The core legal instruments are:

  • Therapeutic Goods Act 1989 — the primary legislation establishing the TGA's powers and the legal basis for regulating medical devices in Australia.
  • Therapeutic Goods (Medical Devices) Regulations 2002 — the operational regulations covering classification, Essential Principles, conformity assessment procedures, and ARTG inclusion.
  • Essential Principles — the Australian equivalent of the MDR's General Safety and Performance Requirements (GSPR), set out in Schedule 1 of the Medical Devices Regulations .

No device may be imported, supplied, or advertised in Australia unless it is included in the ARTG, with narrow exemptions (custom-made devices, clinical trial supply, Special Access Scheme, Authorised Prescriber pathway) .

Classification follows rules that mirror the EU system closely: Class I, Class IIa, Class IIb, Class III, and Active Implantable Medical Devices (AIMD) as a separate category. Software as a medical device (SaMD) is classified under rules aligned with EU MDR Rule 11 logic, though the TGA made its own amendments in 2021 that founders should check case by case.

The conformity assessment routes available are: (a) TGA Conformity Assessment Certificate, (b) a comparable overseas regulator certificate (including EU notified body certificates under the MDR), or (c) for Class I non-sterile / non-measuring, a Manufacturer's Declaration of Conformity.

A worked example: a Class IIa SaMD from Vienna

Picture a small Austrian startup with a Class IIa SaMD — a triage decision support tool. They hold:

  • A valid MDR Annex IX QMS certificate from their EU notified body.
  • An ISO 13485:2016+A11:2021 certificate.
  • A full technical file compiled per MDR Annex II and III.
  • A Clinical Evaluation Report and first PMS report.

To enter Australia, they need to:

  1. Appoint an Australian Sponsor. This can be a distributor, a subsidiary, or a specialised sponsor-as-a-service company. The sponsor's name and address must appear on the device and in the ARTG entry.
  2. Map the classification. A Class IIa under EU MDR is usually Class IIa in Australia — but the mapping must be documented, not assumed. The software-specific rules require a careful re-read.
  3. Select the conformity assessment evidence. Because they already hold an EU notified body certificate under the MDR, they can use it as "comparable overseas regulator" evidence. This avoids the TGA doing its own conformity assessment from scratch.
  4. Submit the Device Application and Application Audit (if selected). For Class IIa, the TGA may select the application for a non-mandatory audit. For Class IIb and above, application audits become mandatory or very likely.
  5. Pay the annual charges. ARTG inclusion is not a one-off fee — there are annual charges, and they scale by class.

End-to-end, a clean Class IIa SaMD inclusion for a sponsor who knows what they are doing typically lands in 4–8 months. The bottleneck is almost never the technical file if you come from EU MDR — it is the sponsor agreement, the labelling rework, and the application audit queue.

The Subtract to Ship playbook for entering Australia

Do not rebuild. Reuse.

Step 1 — Treat Australia as an add-on, not a rewrite. Your MDR technical file is 90% of what the TGA wants. Your GSPR checklist maps almost line-for-line onto the Essential Principles. Your CER is acceptable. Your risk management file per EN ISO 14971:2019+A11:2021 is acceptable. Do not recommission work.

Step 2 — Choose the sponsor model deliberately. You have three options:

  • Distributor as sponsor. Cheapest upfront. Dangerous if the relationship breaks — the ARTG entry legally belongs to the sponsor, not you.
  • Dedicated sponsor service. Neutral third party who holds the ARTG entry for you. Costs more annually but you keep control.
  • Own Australian entity. Only makes sense once you are scaling locally.

For a first entry, a dedicated sponsor service is usually the right Subtract-to-Ship call. It removes the distributor-lock-in risk and you can switch distributors without losing your ARTG entry.

Step 3 — Lean on MDSAP if you already have it. The TGA is a founding MDSAP member. If you already completed an MDSAP audit (or are going to do one for Canada or the US anyway), the QMS evidence component of your TGA conformity assessment is handled. MDSAP does not replace ARTG inclusion — you still need to apply — but it removes one layer of friction.

Step 4 — Redo the labels, not the documentation. This is where founders trip. Australian labels require:

  • English language.
  • Sponsor name and address.
  • Conformity mark requirements that differ from CE.
  • Claims aligned with the intended purpose in the ARTG entry.

Redo labels before you submit, not after. TGA rejections over labelling are the single most common post-submission deficiency.

Step 5 — Budget for annual charges, not just inclusion fees. The ARTG annual charge is not trivial and scales by class. Build it into your 3-year commercial model, not your launch budget.

Step 6 — Plan for UDI. Australia's UDI framework is being phased in and will apply progressively to different device classes . If you already have UDI for EUDAMED, you are positioned well — but the Australian database is separate.

Reality Check

Run through these before you spend a euro on Australian market entry:

  1. Do you have a valid CE certificate issued by an EU notified body under MDR (EU) 2017/745, and does it cover exactly the device variant you want to sell in Australia?
  2. Have you formally mapped your device's EU MDR class to an Australian class using the Australian classification rules, and documented the reasoning?
  3. Have you chosen between a distributor-as-sponsor, dedicated sponsor service, or own-entity model — and written down why?
  4. Do you hold MDSAP certification, or do you have a planned pathway to obtain it? If not, have you priced the alternative conformity assessment route?
  5. Have you reviewed your labelling against Australian requirements — sponsor details, English, symbols, conformity marks?
  6. Does your annual business model include the recurring ARTG charge and sponsor fees, or are you assuming a one-off cost?
  7. Have you checked whether your device class triggers a mandatory or likely application audit, and have you priced the TGA fees for that audit?
  8. Is your post-market surveillance system set up to meet Australian vigilance reporting timelines, which differ in some details from MDR Articles 87–92?

If you answered "no" or "not sure" to more than two, stop and do the mapping exercise before you talk to sponsors.

Frequently Asked Questions

Does a CE mark automatically let me sell in Australia? No. A CE certificate is valuable evidence the TGA can accept as part of the conformity assessment, but you still need an ARTG entry, an Australian sponsor, compliant labelling, and your device class-specific application to be accepted by the TGA.

How long does ARTG inclusion take for a Class IIa device coming from an EU MDR certificate? In clean cases, 4–8 months from submission. Application audits, labelling deficiencies, and classification disputes are the usual reasons it stretches past a year.

Can my EU distributor be my Australian sponsor? Only if they are an Australian legal entity. An EU distributor with no Australian presence cannot be the sponsor. In practice, founders either use an Australian distributor with regulatory capability or a dedicated sponsor-as-a-service firm.

Is MDSAP required for Australia? No, it is not mandatory. The TGA accepts MDSAP certificates as evidence of QMS conformity, which streamlines the conformity assessment step. If you are already doing MDSAP for Canada or the US, Australia becomes almost free to add.

How does Australian classification compare to EU MDR classification? Very closely, with some software-specific differences introduced in 2021. Most devices land in the same class, but every classification must be re-justified under the Australian rules, not copy-pasted from your MDR classification justification document.

Who handles post-market vigilance — me or the sponsor? The sponsor is the legal entity accountable to the TGA, but you as the manufacturer supply the data and do the root cause analysis. Your sponsor agreement must define the handoff, the timelines, and who reports what to whom — otherwise you will miss TGA deadlines.

Sources

  1. Therapeutic Goods Act 1989 (Commonwealth of Australia), as amended.
  2. Therapeutic Goods (Medical Devices) Regulations 2002 (Commonwealth of Australia), as amended.
  3. Regulation (EU) 2017/745 on medical devices, consolidated text. Article 10, Annex IX.
  4. EN ISO 13485:2016+A11:2021 — Medical devices — Quality management systems — Requirements for regulatory purposes.
  5. IMDRF Medical Device Single Audit Program (MDSAP) framework documents.