ARTG to MDR: EU Authorized Representative for Australian Medical Device Manufacturers
Australia's device framework is the closest structural cousin the EU has outside Europe: Essential Principles, conformity assessment procedures, a Class I to III scale and a register of authorized goods. That familiarity is precisely what catches Australian manufacturers out, because the resemblance is architectural and the law is entirely separate. This page works through what the TGA gives you, what MDSAP buys and does not buy, and where an Essential Principles checklist stops being useful.
A framework that looks European, and the trap built into the resemblance
Of all the third countries a European notified body deals with, Australia is the one whose regulatory architecture feels most familiar. The Therapeutic Goods (Medical Devices) Regulations 2002 set out Essential Principles in Schedule 1, conformity assessment procedures in Schedule 3, and a classification scheme running Class I, IIa, IIb, III and AIMD alongside a separate IVD scheme. Anyone who has worked an EU file will recognise the furniture immediately.
That recognition is the problem. The Australian framework was built on the structure of the old European directives and has since diverged from what MDR 2017/745 actually requires. It is Australian law, administered by the TGA, operating in Australia. None of it has effect in the Union, and — more dangerously — the parts that look identical are not.
ARTG inclusion, the sponsor, and manufacturer evidence
Supply in Australia runs through the Australian Register of Therapeutic Goods. An Australian sponsor holds the ARTG entry and applies for inclusion; the manufacturer holds the evidence. The TGA requires manufacturer evidence — a conformity assessment certificate or equivalent — before a device can be included, and it selects a proportion of applications for audit.
Australian sponsors are sometimes described to European manufacturers as the Australian version of the authorized representative. They are not the same role. A sponsor holds the market authorisation and imports or exports the goods. An authorized representative under MDR holds no authorisation at all; it holds a mandate, verifies the manufacturer's conformity work, keeps documentation available, registers economic operators and devices, and answers to competent authorities. The two roles overlap only in that both are locally established.
Essential Principles and GSPRs: same idea, different law, different content
This is where Australian projects go wrong most often. Teams take the Essential Principles checklist that satisfied the TGA and re-label its columns as a general safety and performance requirements checklist. It does not survive review.
| Australian requirement | Where it sits in law | MDR analogue | Directly transferable? |
|---|---|---|---|
| Essential Principles | Schedule 1, Therapeutic Goods (Medical Devices) Regulations 2002 | General safety and performance requirements, MDR Annex I | No. Different numbering and different scope; the evidence underneath is often reusable, the mapping is not. |
| Conformity assessment procedures | Schedule 3 of the same Regulations | MDR Annexes IX, X and XI, selected under Art. 52 | No. Different procedures, different bodies, different certificates. |
| ARTG inclusion | Therapeutic Goods Act 1989 and the Regulations | EU declaration of conformity under Art. 19 plus notified body certificate | No. An ARTG entry is an Australian market authorisation. |
| Australian sponsor | Therapeutic Goods Act 1989 | Authorized representative, MDR Art. 11 | No. Different role, different obligations, must be established in the Union. |
The concrete divergences worth checking first: MDR Annex I, Chapter III governs information supplied with the device in far more detail than the Australian equivalent, and Section 23 alone will drive a rewrite of your label and instructions for use. MDR Annex I also carries requirements on devices incorporating substances, on software life cycle and IT security, and on devices with a diagnostic or measuring function, that do not sit one-to-one against Schedule 1. And MDR Annex VIII, Rule 11 classifies decision-support software as class IIa, IIb or III according to the severity of harm, which frequently sits above the Australian outcome for the same product.
MDSAP: what the TGA accepts, and what a notified body will not
Australia is a founding participant in MDSAP, alongside Brazil, Canada, Japan and the United States. The TGA assesses MDSAP audit reports and certificates as part of the evidence sponsors and manufacturers need, and says it will usually not audit a manufacturer already audited under MDSAP, while reserving the right to do so. For an Australian manufacturer that is a substantial saving.
It buys nothing directly in Europe. The European Union is not an MDSAP participating regulatory authority and no notified body acts as an MDSAP auditing organisation on the EU's behalf. What carries is the standard underneath: MDSAP audits are built on ISO 13485, and a system built to satisfy it will be recognisable under MDR Annex IX. The notified body will still perform its own assessment, will still audit your premises, and will still test the MDR-specific elements of Art. 10(9) that ISO 13485 does not contain — the regulatory compliance strategy, GSPR identification, clinical evaluation under Art. 61 and Annex XIV, UDI verification under Art. 27(3), post-market surveillance under Art. 83 and vigilance under Arts. 87 to 92.
Certificates flow into Australia, not out of it
The TGA operates arrangements for using market authorisation evidence and assessments from comparable overseas regulators, and EU notified body certificates have long been part of how devices reach the ARTG. Manufacturers who have watched European certificates open the Australian door sometimes assume the traffic runs both ways. It does not. The Union operates no reciprocal recognition of Australian conformity assessment, and an Australian conformity assessment body determination has no standing under MDR.
The practical consequence is that a manufacturer who has only ever used an Australian route has, at the point of turning towards Europe, no certificate that any notified body can build on. That is a project, not a filing.
From one English-language market to twenty-four official languages
Australian instructions for use are written once, in English. MDR is explicit that this is not the Union model: "Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient." (MDR Art. 10(11))
The choice of language belongs to each Member State, not to the manufacturer and not to the distributor, and the obligation attaches to whatever Section 23 requires rather than to whatever your Australian artwork happens to contain.
The mandate, and what it will not move off your desk
Manufacturers occasionally hope the representative absorbs the compliance workload. The Regulation forecloses it: "The mandate referred to in paragraph 3 of this Article shall not delegate the manufacturer's obligations laid down in Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and (12)." (MDR Art. 11(4)) Technical documentation, risk management, clinical evaluation, the quality management system, post-market surveillance and labelling all stay with you.
Medex Kurumsal Danışmanlık holds EUDAMED SRN TR-AR-000057550 as an authorized representative, and is separately registered as a manufacturer under TR-MF-000057496 and as an importer. Actor registration, UDI/device registration, notified bodies and certificates, and market surveillance became mandatory modules of EUDAMED on 28 May 2026. Our person responsible for regulatory compliance is in-house, a partner of the firm, with a deputy; our offices are in Ankara, İstanbul and Gdańsk; pricing is published and class-based with annual fees from EUR 1000. See pricing and the authorized representative service.
What Australian manufacturers and sponsors ask
We hold an ARTG inclusion. Does it count for anything in Europe?
Not as an authorisation. The evidence behind it — risk management file, verification and validation testing, biological evaluation, clinical data — is frequently reusable inside an MDR technical file. The inclusion itself, and the Essential Principles checklist supporting it, are not.
Our MDSAP certificate covers the TGA. Will a notified body accept it?
Not as a substitute for its own assessment. The EU does not participate in MDSAP. A notified body will recognise the ISO 13485 system underneath and can presume conformity for what the harmonised standard covers, then audit everything MDR adds on top, on your premises.
Our device is Class IIa in Australia. Is it class IIa under MDR?
Work it through Annex VIII from first principles rather than assuming. Software, reusable surgical instruments and devices incorporating substances are the categories where the Australian and EU answers most often part company, and Rule 11 in particular moves products upward.
Can our Australian sponsor act as our EU authorized representative?
No. An authorized representative must be a natural or legal person established within the Union that has received and accepted a written mandate. An Australian sponsor cannot hold the role regardless of how well it performs the Australian one. Talk to us at contact about splitting the two cleanly.