CE Marking to TGA: How to Use Your EU MDR Certification to Enter the Australian Market

If your medical device already holds CE Marking under EU MDR 2017/745, you may be closer to selling in Australia than you think. The TGA recognises EU MDR certification as valid manufacturer evidence for ARTG inclusion, meaning you can often bypass a full TGA conformity assessment entirely. Here’s what you need to know.

Why Australia Is the Natural Next Step After CE Marking

For medical device manufacturers who have navigated the rigorous requirements of EU MDR 2017/745, the Australian market offers a genuinely compelling opportunity and a far lower incremental regulatory burden than most people expect.

Australia imports over 90% of its medical device market needs. It has a sophisticated healthcare system, an established reimbursement framework through the Prostheses List, and a regulator (the Therapeutic Goods Administration (TGA)) that has actively worked to align its requirements with international frameworks, including the EU MDR. The result is that for manufacturers who have already done the hard work of achieving EU MDR compliance, the path to Australian market access is more straightforward than for any other major market outside Europe.

The key mechanism is the TGA’s abridged pathway: an ARTG application process that uses your existing EU MDR Notified Body certification as the manufacturer evidence, rather than requiring the TGA to conduct its own independent conformity assessment. In many cases, this means your existing EU technical documentation, your Notified Body certificate, and your CE Marking can directly underpin an ARTG application without rebuilding your technical file from scratch.

Key fact: Over 90% of medical device ARTG entries requiring third-party certification historically rely on CE Marking certification. Australia has deliberately structured its regulatory system to make this pathway efficient.

How the TGA’s Abridged Pathway Works for EU MDR-Certified Devices

The TGA’s abridged pathway for overseas manufacturers has two core components: Manufacturer Evidence (ME) and the ARTG inclusion application itself. Understanding the distinction between these two steps is important.

Step 1: Submit Your Manufacturer Evidence (ME)

The Manufacturer Evidence is the document that demonstrates your quality management system and conformity assessment credentials to the TGA. For EU MDR-certified manufacturers, the accepted forms of ME are:

• An Annex IX Chapter I certificate (QMS assessment) issued by your EU Notified Body. This is the primary form of ME used by most MDR-certified manufacturers
• An Annex XI (QMS full quality assurance) certificate, where applicable
• For Class III and AIMD devices: the Annex IX Chapter II certificate (assessment of technical documentation) or Annex X certificate is also required alongside the QMS certificate

ME submission is processed by the TGA relatively quickly, typically within a week, and carries no TGA application fee. Once your ME is accepted, it covers all devices of the same manufacturer, meaning you only need to submit ME once and can then list multiple devices against it.

✔ Practical tip: If your Notified Body has issued you both an Annex IX Chapter I and Chapter II certificate (as is common for higher-risk devices), submit both as part of your ME package. This gives the TGA the strongest possible evidence base and reduces the likelihood of audit selection.

Step 2: Submit the ARTG Inclusion Application

Once your ME is accepted, your Australian Sponsor submits the ARTG inclusion application through the TGA’s e-Business portal. The application covers devices of the ‘same kind’; a defined grouping that allows multiple product variants to be captured under a single ARTG entry for lower-risk device classes. For Class III devices and AIMDs, a separate application is required for each Unique Product Identifier (UPI).

The application requires: device description and intended purpose, Australian device classification, GMDN code, labelling and instructions for use (Australian-specific requirements apply), a cross-reference to your accepted ME, and a Declaration of Conformity with Australian Essential Principles.

✔ Practical tip: Australia’s Essential Principles are closely aligned with the EU MDR’s General Safety and Performance Requirements (GSPRs). If your GSPR checklist is well-prepared, mapping to the Australian Essential Principles is generally straightforward. Practical RA can review your existing documentation and identify any gaps before submission.

The Mandatory Audit Question: When Is It Required?

One of the most commonly misunderstood aspects of TGA registration is the audit requirement. Many manufacturers assume a mandatory audit is inevitable for higher-risk devices — but recent TGA reforms have significantly changed this picture for EU MDR-certified manufacturers.

As of the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024, application audits are now mandatory only in a narrow set of circumstances. For medical devices supported by a valid EU MDR 2017/745 Notified Body certificate, mandatory audits are not required for Class I, Class IIa, Class IIb, or Class III devices provided the EU MDR certificate has not been suspended or revoked.

Important update: Class III devices and AIMDs supported by EU MDR 2017/745 certification are no longer subject to mandatory TGA audit. This is a significant recent change that substantially reduces the timeline and cost burden for high-risk device manufacturers with current MDR certification.

The mandatory audit requirement now applies primarily to Class III devices still relying on legacy MDD or AIMDD certificates (rather than EU MDR) and certain IVD categories. This creates a clear and practical incentive for manufacturers to ensure their EU MDR certification is current before applying for TGA registration.

The TGA retains the right to select any application for a non-mandatory audit at its discretion, but no audit fee applies in these cases. If selected for audit, Class IIb and Class III devices may be required to provide clinical evaluation reports, risk management reports, and performance data which, for EU MDR-certified manufacturers, should already exist in your technical documentation package.

✔ Practical tip: If your EU MDR Notified Body certificate is due for renewal, time your TGA application to coincide with certificate renewal. A current, valid MDR certificate is your single most important asset in the TGA application process.

What’s Different in Australia: Key Compliance Considerations

While the abridged pathway significantly reduces the regulatory burden for EU MDR-certified manufacturers, there are important Australia-specific requirements that must be addressed. Treating the TGA application as a simple rubber-stamp of your CE Marking is one of the most common mistakes manufacturers make.

1. Australian Device Classification

Australia uses a risk-based classification system closely modelled on the EU framework, with Classes I, IIa, IIb, and III. However, there are differences. All disinfectors are classified as Class IIb in Australia regardless of EU classification. Devices in contact with the central nervous system may be classified differently from their EU equivalent. It is important to confirm your Australian classification before submitting an ARTG application — incorrectly classifying your device can result in application rejection and delays.

2. Australian-Specific Labelling Requirements

Labelling must comply with the Therapeutic Goods (Medical Devices) Regulations 2002 Schedule 3 requirements. Key Australian-specific requirements include: the name and address of the Australian Sponsor must appear on the label (or in the Instructions for Use for some device types); the ARTG inclusion number must be displayed on the label after inclusion is granted; and where applicable, the Australian equivalent of the CE marking symbol requirements applies. For manufacturers already producing EU MDR-compliant labels, these changes are typically minor but must be addressed before devices can be supplied.

3. Declaration of Conformity with Australian Essential Principles

You must prepare a Declaration of Conformity stating that your device meets the Australian Essential Principles (set out in Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002). As noted above, the Essential Principles are substantially aligned with EU MDR GSPRs, but the declaration must specifically reference compliance with Australian requirements — your EU Declaration of Conformity cannot simply be reused verbatim.

4. UDI Requirements — New from 2025

Australia’s Unique Device Identification (UDI) regulatory framework came into effect on 24 March 2025, with a phased compliance schedule running through to 2030. Class III and Class IIb devices must meet UDI labelling and AusUDID data submission requirements by 1 July 2026. Class IIa devices must comply by 1 July 2027. For manufacturers already compliant with EU MDR UDI requirements, Australian UDI compliance is largely aligned — but the AusUDID is a separate database requiring separate data submission.

✔ Practical tip: If your devices are EU MDR UDI-compliant, you are well-positioned for Australian UDI compliance. The key additional step is registering your UDI-DI data in the AusUDID (Australia’s national UDI database) within 30 days of first supply in Australia.

5. Post-Market Surveillance and Reporting Obligations

Once your device is included in the ARTG, ongoing post-market compliance obligations apply under Australian law. These include adverse event and incident reporting to the TGA, maintenance of current manufacturer evidence (your Notified Body certificate must remain valid), notification of changes that may affect the ARTG entry, and compliance with TGA recall or market action requests. Your Australian Sponsor is responsible for many of these obligations on your behalf — which is why choosing an engaged, experienced Sponsor matters.

What About FDA-Cleared Devices? An Important Distinction

A question we receive regularly is whether US FDA clearance can be used in the same way as EU MDR CE Marking for TGA registration. The answer is yes, but with an important additional requirement.

FDA 510(k) clearance and De Novo decisions are accepted by the TGA as product conformity assessment evidence for Class IIa and Class IIb devices, and Class 2 and Class 3 IVDs. However, when leveraging FDA clearance (rather than CE Marking), the TGA requires an MDSAP certificate as the manufacturer evidence; an ISO 13485 certificate alone is not sufficient for new IVD device applications, and is not the preferred pathway for medical devices.

This means manufacturers with FDA clearance but no EU MDR certification need to either: hold an MDSAP certificate with Australia in scope, or obtain EU MDR CE Marking and use that as the primary TGA pathway instead. For manufacturers already holding EU MDR CE Marking and FDA clearance, the EU MDR certificate is generally the simpler and more efficient route to TGA registration.

Bottom line: If you have both EU MDR CE Marking and FDA clearance, lead with your CE Marking for the TGA application. It is the more direct pathway and does not require MDSAP certification.

A Practical Timeline: What to Expect

For EU MDR-certified manufacturers working with an experienced Australian Sponsor, here is a realistic timeline for ARTG inclusion:

• Week 1–2: Initial assessment of device classification, existing documentation, and Australia-specific gaps. Preparation of Australian labelling and Declaration of Conformity.
• Week 2–3: Manufacturer Evidence submission to the TGA. ME processing typically takes 1–2 weeks with no fee.
• Week 3–4: ARTG inclusion application submission by the Australian Sponsor.
• Week 4–8: TGA review period. For Class I and Class IIa devices with current EU MDR certification, ARTG inclusion within 4–6 weeks of submission is achievable. Class IIb and Class III devices may take longer if selected for non-mandatory audit.

The single biggest variable in timeline is the readiness of your documentation. Manufacturers who approach the TGA application with current, well-organised EU MDR technical documentation, including an up-to-date CER, risk management file, and GSPR checklist, consistently achieve faster outcomes than those who need to reconstruct documentation from scratch.

How Practical RA Can Help

Practical RA is a Melbourne-based regulatory affairs firm with active expertise across EU MDR 2017/745, US FDA, and TGA requirements. Our Australian Sponsor service is specifically designed for overseas manufacturers who already hold EU MDR CE Marking or FDA clearance and are seeking to leverage those approvals for efficient Australian market access.

We understand your existing documentation — because we work with it every day in our EU MDR and FDA consulting practice. This means we can accurately map your CE Marking documentation to TGA requirements, identify genuine gaps (rather than treating every Australia-specific element as a major issue), and manage the TGA application efficiently on your behalf.

Our Australian Sponsor service is led by Tara Silva, who brings direct experience from a large multinational regulatory firm and maintains active professional relationships within the Australian medical device regulatory community. For most clients with current EU MDR certification, we target TGA application submission within 2 weeks of completing our documentation review.

If you’re an EU MDR-certified manufacturer considering the Australian market, we’re happy to provide an initial assessment of your pathway and timeline at no charge. Reach out to our team or contact Tara directly at tara@practicalra.com to discuss your situation.

Ready to explore the Australian market? Contact Practical RA to discuss your EU MDR certification and what’s needed for TGA registration. Initial assessments are provided at no charge.

Key Takeaways

• EU MDR 2017/745 CE Marking is accepted by the TGA as manufacturer evidence for ARTG inclusion. This is the most direct and efficient pathway for overseas manufacturers entering the Australian market
• Following 2024 regulatory amendments, Class III devices with current EU MDR certification are no longer subject to mandatory TGA audit, a significant change that reduces timeline and cost for high-risk device manufacturers
• Australia-specific requirements still apply: device classification must be confirmed, labelling must be updated, a Declaration of Conformity with Australian Essential Principles must be prepared, and UDI data must be submitted to the AusUDID
• For manufacturers with both EU MDR CE Marking and FDA clearance, the CE Marking route to TGA registration is generally more direct. FDA clearance requires an MDSAP certificate as manufacturer evidence
• Working with an Australian Sponsor who understands EU MDR documentation significantly reduces the time and cost of TGA registration