If your medical device already carries a CE (Conformité Européenne) mark, a United States Food and Drug Administration (FDA) clearance or approval, or a Medical Device Single Audit Program (MDSAP) certificate, you are probably wondering how much of that work you can reuse in Australia. The short answer: quite a lot. The Therapeutic Goods Administration (TGA) recognises and relies on a defined set of approvals from comparable overseas regulators when it decides whether to include a device in the Australian Register of Therapeutic Goods (ARTG).
The longer answer is that overseas evidence only counts if it is the right document, for the same device, at the right risk class, and it never removes your Australian obligations. This guide walks through what the TGA accepts, what overseas evidence does and does not replace, and the high-level steps to ARTG inclusion.
This article is general information, not legal or regulatory advice. TGA rules change, so always confirm the current requirements on the TGA website before you apply.
What the TGA's current guidance says
The TGA's main reference is its guidance Use of market authorisation evidence from comparable overseas regulators and assessment bodies for medical devices (including IVDs), Version 2.1 (May 2026). IVD means in vitro diagnostic medical device. The guidance explains which overseas assessments and approvals applicants:
- can use to support an abridged (shortened) assessment of an application for a TGA conformity assessment certificate, and
- must provide with applications for inclusion of medical devices, including IVDs, in the ARTG.
The guidance states that these arrangements are set by legal instruments, including the Therapeutic Goods (Overseas Regulators) Determination 2022 and the Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018, as amended (including Amendment Determination (No. 3) 2024). If the guidance and an instrument are inconsistent, the instrument applies. Note that the TGA's related web page still lists the Therapeutic Goods (Overseas Regulators) Determination 2018, so check the current instrument on the Federal Register of Legislation before you rely on it.
Which overseas regulators does the TGA treat as comparable?
The TGA lists the following comparable overseas regulators and assessment bodies:
- European Union (EU) notified bodies: certificates under the Medical Device Directive 93/42/EEC (MDD), the Active Implantable Medical Device Directive 90/385/EEC (AIMDD), the IVD Directive 98/79/EC (IVDD), the Medical Device Regulation (MDR) or the IVD Regulation (IVDR).
- US FDA: premarket approval (PMA), 510(k) premarket notification and De Novo decisions.
- Health Canada: approvals and medical device licences.
- Japan: pre-market approvals or certification from the Ministry of Health, Labour and Welfare (MHLW) or the Pharmaceuticals and Medical Devices Agency (PMDA).
- Singapore Health Sciences Authority (HSA): registrations or approvals.
- United Kingdom (UK) approved bodies: certificates under the UK Medical Devices Regulations 2002 (which apply the MDD, AIMDD and IVDD).
- MDSAP: certificates and audit reports issued under the Medical Device Single Audit Program.
When deciding whether to recognise a regulator, the TGA uses five criteria: comparability of the regulatory framework; membership of the International Medical Device Regulators Forum (IMDRF); a life-cycle approach with robust post-market vigilance; communication and cooperation with the TGA; and the regulator's assessment expertise.
The "same device" test
Overseas documents only help if they were issued for the same medical device, or medical device group, that you want to include in the ARTG. According to the TGA, the device must have the same design, intended purpose and user, and be intended for the same indications.
If your documents do not cover every device of the kind in your application, the TGA may impose conditions that limit the ARTG entry to the devices that are covered. You can use more than one product-assessment document, such as several 510(k) summaries, to cover the range you intend to supply.
Before you prepare anything else, compare the device description, models, intended purpose and indications on your overseas certificate with what you plan to state in the Australian application. Mismatches are easier to fix at this point than after lodgement.
Two kinds of evidence: Manufacturer Evidence and product assessment
For ARTG inclusion, the TGA splits overseas evidence into two parts:
- Manufacturer Evidence: a conformity assessment document about the manufacturer's quality management system (QMS), or a Declaration of Conformity for a system or procedure pack. It must be submitted, assessed and accepted before you apply for ARTG inclusion.
- Evidence of product assessment: the document showing the device itself was assessed or approved. It is attached to the ARTG inclusion application.
Which documents you need, and from which regulator, depends on the device's Australian classification. If you have not confirmed the class yet, start with our guide to medical device classification in Australia.
Examples from the TGA's evidence table
The table below summarises examples the TGA has published. It is not the full table. Check the current TGA guidance for your exact class and evidence type.
| Regulator | Australian class | Manufacturer Evidence (QMS) | Product assessment evidence |
|---|---|---|---|
| EU (MDR) | Class III | Annex IX (QMS) certificate | Annex IX (assessment of technical documentation) certificate |
| EU (MDD) | Class III | Annex II.3 certificate | Annex II.4 (design examination) certificate |
| US FDA | Class III | MDSAP certificate (or PMA) | PMA, or 510(k) clearance |
| US FDA | Class IIb | MDSAP certificate | 510(k) summary or De Novo decision summary |
| Health Canada | Class III | MDSAP certificate | Class IV medical device licence |
| Health Canada | Class IIb | MDSAP certificate | Class III medical device licence |
| Japan (MHLW / PMDA) | Class III | QMS certificate or MDSAP certificate | Pre-market approval certificate |
| Singapore HSA | Class III | Extract from the Singapore Register of Health Products as a Class D medical device (covers both) | Not applicable (covered by the register entry) |
Product approvals from the FDA and Health Canada do not cover the manufacturer's QMS, which is why the TGA asks for an MDSAP certificate alongside them. Singapore HSA approvals cover both the QMS and the product, so no separate QMS document is needed.
EU CE certificates: MDD versus MDR
The TGA accepts EU notified body certificates issued under both the older Directives (MDD, AIMDD, IVDD) and the newer Regulations (MDR, IVDR). The difference that matters in Australia is audit treatment:
- Since 1 July 2024, a Class III device application supported by an EU MDD certificate is one of the cases the TGA says must be selected for a mandatory application audit, with fees.
- Since 1 July 2024, devices containing medicinal, microbial, recombinant or animal-origin substances can be supported by the same wider range of overseas approvals as other Class III devices (for example FDA, Health Canada, Japan or Singapore), instead of only TGA or EU certification.
Check that your CE certificate is current, unredacted and covers the exact models you plan to supply before you rely on it. The TGA rejects expired certificates and certificates with redacted or altered information.
A CE Declaration of Conformity is not enough by itself. The TGA requires an Australian Declaration of Conformity made under Schedule 3 of the Therapeutic Goods (Medical Devices) Regulations 2002. A declaration made to the EU MDD requirements is not acceptable.
US FDA pathways the TGA recognises
The TGA lists three FDA outcomes: PMA, 510(k) clearance and De Novo decisions. Which one works depends on the Australian class:
- For a Class IIb device, the TGA's own example lists an MDSAP certificate as Manufacturer Evidence plus a 510(k) summary or De Novo decision summary (or a Health Canada Class III licence or a Japan pre-market approval certificate) as product evidence. If none of these is attached, the application fails preliminary assessment and is refused.
- For a Class III device, the TGA's table lists PMA, or MDSAP certification with a 510(k) clearance. However, a Class III application supported by MDSAP plus 510(k) is one of the cases the TGA says must go to mandatory application audit.
FDA approvals cover the product, not the QMS, so plan for MDSAP certification that includes Australia (see below).
MDSAP and Australia
MDSAP lets one audit of a manufacturer's QMS satisfy several participating regulators, including the TGA. The TGA uses MDSAP in three ways: it accepts MDSAP certificates as Manufacturer Evidence, it may use MDSAP audit reports to abridge a TGA conformity assessment, and it may accept MDSAP reports in place of initial and routine TGA audits.
The conditions are strict:
- The Australian regulatory requirements must have been covered in the audit, and the certificate must show the manufacturer was assessed and found to comply with the relevant parts of the Therapeutic Goods (Medical Devices) Regulations 2002. Failing this is a common reason the TGA rejects Manufacturer Evidence.
- The TGA can only use MDSAP certificates and reports that relate to manufacturers (the legal entity placing the device on the market under its own name), not to a supplier site alone.
- If you rely on EU certification for ARTG inclusion, MDSAP rules still require Australia to be included in the MDSAP audit if the product is, or will be, supplied in Australia. This applies to all classes other than Class I devices and Class 1 IVDs.
MDSAP versus ISO 13485. An MDSAP audit is built on ISO 13485 (the international QMS standard for medical devices), but an ISO 13485 certificate on its own is not acceptable Manufacturer Evidence for non-IVD medical devices. The TGA's guidance has a narrow, time-limited exception for some IVDs with EU Declarations of Conformity made under IVDD Annex III before 26 May 2022: it applies to Class 3 IVD applications submitted before 26 May 2026 and Class 2 IVD applications submitted before 26 May 2027. For more on certification, see our ISO 13485 medical devices page.
What overseas evidence does and does not replace
It can replace or shorten:
- a full TGA conformity assessment, when the right overseas documents are provided as Manufacturer Evidence and product evidence, and
- parts of a TGA conformity assessment, through abridgement based on overseas assessment reports.
It does not replace:
- An Australian sponsor. The TGA remains responsible for including devices in the ARTG, and applications are made by the Australian sponsor.
- Australian classification. You must classify the device under Australian rules, which can differ from the overseas class.
- The Australian Declaration of Conformity under Schedule 3 of the Regulations.
- The Essential Principles. All devices supplied in Australia must meet the Australian essential principles of safety and performance, including labelling requirements, and the TGA can check this through an application audit.
- English-language documents. Anything that accompanies the application must be in English or come with a certified English translation.
- Audit. The TGA can select any application for audit.
High-level steps to ARTG inclusion using overseas evidence
- Confirm the Australian classification of your device. See medical device classification in Australia.
- Match your overseas documents to the TGA's evidence table for that class, and check the "same device" test.
- Submit Manufacturer Evidence through the TGA Business Services (TBS) portal. The TGA returns a Manufacturer Evidence identifier, which you need for the ARTG application. There is no fee for a Manufacturer Evidence application. It is not needed for Class I non-sterile, non-measuring devices or Class I IVDs.
- Prepare the Australian Declaration of Conformity and your Essential Principles evidence.
- Lodge the ARTG inclusion application with the product-assessment evidence attached.
- Pass preliminary assessment. If required documents are missing, the application is refused.
- Respond to any application audit.
For the wider process, see our guide to the TGA medical device approval regulations and process.
Application audits
From 1 July 2024, the TGA narrowed mandatory application audits to higher-risk devices. Regulation 5.3 of the Therapeutic Goods (Medical Devices) Regulations 2002 lists the kinds of applications that are prescribed for mandatory audit, including Class III devices, Class 3 and Class 4 IVDs, Class 4 in-house IVDs, and IVDs for self-testing or point-of-care testing. The regulation also sets out circumstances where the mandatory audit does not apply, depending on the evidence provided.
In practice, the TGA says mandatory audits for Class III medical devices now apply only to applications supported by EU MDD certification, or by MDSAP certification plus 510(k) evidence. Mandatory audits attract assessment fees.
The TGA may also select any other application for a non-mandatory audit, without assessment fees. Reasons include concerns about the application, or safety and performance signals about the device or similar devices. For the government fees that apply, see our guide to TGA approval costs and fees.
Common reasons Manufacturer Evidence is rejected
The TGA lists these common reasons:
- the document is not an acceptable conformity assessment document (for example, an ISO 13485 certificate for a non-IVD device)
- the evidence does not match the application
- the evidence is not in English and has no certified translation
- more than one document, or an irrelevant document, was submitted (only one piece of Manufacturer Evidence at a time)
- an MDSAP certificate does not show compliance with the relevant parts of the Australian Regulations
- pages, schedules or attachments are missing
- the certificate is expired, redacted or altered, or its QR code does not return a valid certificate
- the manufacturer's name or address changed without supporting documents
- the manufacturer's QMS or the legal manufacturer has changed.
Next steps
If you hold CE, FDA, MDSAP or other overseas approvals and want to know which documents will work for your device class in Australia, our team can map your evidence against the TGA's requirements. Learn more about our medical device regulatory services.
For a quote on preparing your Manufacturer Evidence and ARTG application, contact R2 Pharma Solutions.