Australian regulatory & market access
Pacific Access turns a complex regulatory journey into a clear, practical route—from device classification and evidence strategy to ARTG inclusion, Australian market entry and ongoing compliance.
Independent Australian guidance · Last regulatory review: July 2026
First, one important distinction
A medical device normally needs to be included in the Australian Register of Therapeutic Goods (ARTG) before it is imported, exported from Australia or supplied. The ARTG entry is held by the Australian sponsor and generally covers a kind of medical device, not necessarily each model as a separate entry.
Phase 1 · Assess your product
In practical terms, it is a product intended for a medical purpose in humans—such as diagnosis, prevention, monitoring or treatment— whose main intended action is not achieved by pharmacological, immunological or metabolic means.
The same technology can be regulated differently depending on its claims and intended use. A wellness app may sit outside the device framework, while software that diagnoses or recommends treatment may be a medical device.
Check the TGA overviewCosmetics, medicines, disinfectants, personal protective equipment and general consumer products can sit under different rules. Borderline and combination products need careful review.
Also check exclusions, exemptions and special-access pathways.
Phase 1 · Assess your product
Answer from the manufacturer’s documented intended purpose—not how a customer might choose to use the product.
Product screening
Risk classification
Phase 1 · Assessment step 3 of 3
Select the Australian class and the strongest regulatory evidence already held by the legal manufacturer.
Manufacturer evidence pathway
All recognised route families
Open the full reference catalogue. Availability depends on class, scope, validity, transition dates and product-level evidence.
Best suited to: Class I non-sterile, non-measuring devices—including reusable surgical instruments; Class 1 IVD; qualifying procedure packs
Australian Declaration of Conformity. No manufacturer-evidence certificate is normally submitted for the basic Class I / Class 1 IVD pathway. Reprocessing evidence must be maintained for reusable surgical instruments.
Best suited to: Any eligible class where the manufacturer seeks Australian certification or does not hold usable overseas evidence
Part 1 Full QMS, or another applicable Schedule 3 procedure. Design/type examination is added where the device class and procedure require it.
Best suited to: Class Is, Im, IIa, IIb and III medical devices, plus eligible EU MDR evidence for reusable surgical instruments
Typically Annex IX Chapter I QMS or Annex XI product-conformity certification, with technical-documentation or type-examination evidence where required.
Best suited to: Commonly Class IIa, IIb, III and relevant IVD pathways
MDSAP certificate for the manufacturer plus the matching 510(k) Summary, De Novo Decision Summary, PMA or evidence of exemption, as applicable.
Best suited to: Commonly Class IIa, IIb, III and IVD pathways
MDSAP certificate plus the matching Canadian medical-device licence for the product and risk class.
Best suited to: Commonly Class IIa, IIb, III and relevant IVD pathways
Japanese QMS certificate or MDSAP certificate, paired with the applicable pre-market certificate or pre-market approval.
Best suited to: Devices entered in the Singapore Register of Health Products
Extract or copy of the Singapore register entry at the corresponding Class B, C or D level, subject to the Australian class and device type.
Best suited to: Eligible devices certified under recognised UK arrangements
Relevant approved-body certificate under the UK framework. The exact certificate and product-assessment evidence must match the Australian class.
Best suited to: Class 2, 3 and 4 IVD medical devices
Annex IX Chapter I QMS or eligible Annex XI evidence, plus technical-documentation assessment for higher-risk, self-test, near-patient or companion-diagnostic pathways as applicable.
Your personalised next step
Turn your three tool results into a branded, downloadable summary and choose whether you would like to discuss professional ARTG support.
Phase 2 · Prepare the application
There is no single document that registers every device. Your route depends on classification, intended purpose, manufacturer evidence and whether the application requires an audit.
The manufacturer’s stated purpose is central. Record who uses the product, for whom, what it does and how it achieves that purpose.
Classification is risk-based. Higher-risk devices generally require stronger conformity assessment evidence and more TGA scrutiny.
An overseas manufacturer needs an Australian-based person or company to take legal responsibility for supply and interact with the TGA.
The manufacturer must demonstrate an appropriate quality system and compliance with the Essential Principles. Accepted overseas evidence may be usable in many pathways.
The sponsor submits an application for inclusion of the relevant ‘kind of medical device’ in the ARTG and pays the application fee.
Some applications are selected or required for audit. Supply the requested technical, clinical, labelling and certification evidence promptly.
Phase 3 · Supply in Australia
ARTG inclusion is the gateway—not the finish line. Before launch, make sure the product, information and supply chain remain consistent with the approved intended purpose and evidence.
Confirm the correct device kind is included and the sponsor details are accurate.
Meet Essential Principles information requirements, including sponsor details where required.
Claims must be accurate, supportable and consistent with the intended purpose and advertising law.
Use traceable supply arrangements and retain distribution and complaint records.
From 1 July 2026, mandatory Australian UDI requirements began for certain higher-risk devices, with phased implementation for other classes.
Train relevant staff, establish vigilance contacts and make the technical file accessible to the sponsor.
Phase 4 · Maintain the inclusion
The sponsor and manufacturer must continue to meet regulatory obligations for as long as the device is supplied in Australia. An unchanged ARTG entry does not mean “nothing to do”.
Pay the TGA annual charge by the due date unless an exemption applies.
Maintain valid conformity assessment certification and notify relevant changes.
Ensure the sponsor can obtain technical documentation and records from the manufacturer.
Report reportable adverse events within the applicable statutory timeframes.
Investigate complaints and conduct recalls or other market actions when necessary.
Meet any device-specific annual reporting, tracking, audit or information-request requirements.
Official resources
Use these official pages to verify the current requirements for your particular device.
Common questions
An overseas manufacturer generally needs an Australian-based sponsor to apply for and hold the ARTG inclusion.
No. Overseas evidence may support the Australian pathway, but the device generally still needs the appropriate Australian sponsor and ARTG inclusion before supply.
Not always. ARTG inclusion is generally by a “kind of medical device”, determined using attributes including sponsor, manufacturer, classification, Global Medical Device Nomenclature code and other characteristics.
It depends on device class, the evidence pathway, whether TGA conformity assessment is required and whether the inclusion application is audited. Always use the current TGA fees and timeframe guidance for planning.