ARTG inclusion through an Australian sponsor.
Conformity assessment evidence, including comparable overseas approvals, Essential Principles and the obligations of your Australian sponsor.
Key facts
Pathways
- Inclusion in the Australian Register of Therapeutic Goods (ARTG) by an Australian sponsor
- Use of comparable overseas regulator evidence, such as EU certificates, FDA decisions, MDSAP or Health Canada licences
- TGA conformity assessment where overseas evidence is not used
- Application audits for certain higher-risk devices
What you will need
- Declaration of conformity
- Manufacturer's conformity assessment evidence
- Essential Principles checklist
- Clinical evidence proportionate to risk
- Labelling and IFU
Sequence and decision points
- 01ClassifyApply the Australian classification rules.
- 02Appoint a sponsorAn Australian entity responsible for supply.
- 03Gather evidenceOverseas approvals or TGA conformity assessment.
- 04ApplyARTG application, with an audit where required.
- 05Include and monitorARTG entry, annual charges and post-market duties.
ISO 13485 evidence through conformity assessment; MDSAP certificates are accepted as evidence.
An Australian sponsor, a legal entity in Australia, must apply for and hold the ARTG entry.
Where MedoQi does not hold this role, we work with your appointed representative or a qualified partner.
Application, audit and annual charges are published by the TGA. Timelines depend on whether an application audit is selected.
After market entry
- Adverse event reporting: 2, 10 or 30 days depending on severity
- Recalls under the Uniform Recall Procedure for Therapeutic Goods
- Annual charges and ARTG maintenance
- UDI requirements as they are phased in
How we help
- ARTG strategy and evidence mapping
- Essential Principles checklist
- Sponsor coordination
- Clinical evidence review
- Post-market reporting support
Delivered through our model: assess, validate, remediate, submit, maintain. How we work
Common questions about Australia
Summary information for orientation. Requirements depend on intended use, classification and device characteristics, and change over time.
Can we use our CE certificate in Australia?
Usually, yes. The TGA accepts comparable overseas regulator evidence, including EU certificates, subject to conditions and a possible audit.
Discuss your device, market or audit with a specialist
Share the device, its class and your target markets. A senior specialist will come back with the likely pathway, the evidence gaps we see and a practical plan.