Is the product a medical device?
Start with the manufacturer’s intended purpose, claims and principal mode of action—not simply the product’s appearance or technology.
Knowledge & resources
Understand the Australian medical-device journey
Plain-language guidance for manufacturers and sponsors, organised around the questions that arise before, during and after ARTG inclusion.
Core knowledge
Six concepts to understand before applying
These summaries are starting points. The precise answer depends on the product, intended purpose and evidence held by the legal manufacturer.
How risk class shapes the pathway
Australian classification is risk-based. Device type, invasiveness, duration, anatomical site, software impact and special features can change the result.
Conformity assessment evidence
The legal manufacturer needs evidence appropriate to the device. Accepted overseas certification may support some Australian pathways, but it does not itself authorise supply.
The Australian sponsor
An overseas manufacturer generally needs an Australian-based sponsor to apply for ARTG inclusion and meet local regulatory responsibilities.
ARTG inclusion
The sponsor applies for inclusion of the relevant kind of medical device. Some applications are selected or required for an application audit.
After market entry
ARTG inclusion brings ongoing duties: annual charges, valid evidence, complaint handling, incident reporting, recalls, changes and information requests.
ARTG roadmap
From intended purpose to ongoing compliance
“Registration” usually means inclusion in the Australian Register of Therapeutic Goods. The inclusion is held by the Australian sponsor and generally covers a kind of medical device.
- 01
Define intended purpose
Record who uses the product, for whom, what it does and how its principal intended action is achieved.
- 02
Confirm device status and class
Check exclusions and product-specific rules, then apply every relevant classification rule and use the highest resulting class.
- 03
Appoint the Australian sponsor
Confirm the local legal entity and put arrangements in place for access to manufacturer evidence, records and vigilance information.
- 04
Establish manufacturer evidence
Confirm the quality-management and product evidence is valid, appropriately scoped and acceptable for the proposed Australian route.
- 05
Apply for ARTG inclusion
Submit the correct application, pay the applicable fee and respond to any TGA application-audit request.
- 06
Launch and maintain
Control labels, claims and distribution, then meet post-market, annual-charge, evidence and change obligations.
Common questions
Frequently asked questions
Can an overseas manufacturer apply directly?
An overseas manufacturer generally needs an Australian-based sponsor to apply for and hold the ARTG inclusion.
Does FDA clearance or a CE mark automatically allow supply?
No. Overseas evidence may support an Australian pathway, but the device generally still needs an Australian sponsor and ARTG inclusion before supply.
Is every model registered separately?
Not always. ARTG inclusion is generally by a kind of medical device, determined using attributes that include sponsor, manufacturer, classification, nomenclature code and other characteristics.
How long will an ARTG application take?
Timing depends on the class, evidence pathway, application type and whether the application is audited. Use current TGA target-timeframe guidance for planning.
What happens after ARTG inclusion?
The sponsor and manufacturer must maintain valid evidence and meet ongoing obligations, including annual charges, incident reporting, recalls, change control and TGA information requests.
Can the online assessment confirm my classification?
No. It provides an indicative starting point. Borderline status, special classification rules and the precise intended purpose may require a closer product-specific review.
Primary sources
Verify requirements with official TGA guidance
Regulatory requirements and guidance change. Use these official pages when planning a specific application or compliance activity.
Apply what you learned