Resources
Regulatory topics for Australian medical device market entry.
These topics help overseas manufacturers understand the questions that usually shape TGA pathway planning, sponsor selection, and post-market readiness.
ARTG
ARTG inclusion explained for overseas manufacturers
What ARTG inclusion means, where sponsor responsibilities fit, and why evidence readiness matters before filing.
Sponsor
Australian sponsor responsibilities after inclusion
Why sponsor duties continue after market entry, including records, reporting, changes, recalls, and TGA communication.
Evidence
Using overseas evidence for Australian market access
How CE, FDA, UKCA, Health Canada, and MDSAP evidence can inform the Australian regulatory pathway.
Readiness
Common causes of delayed TGA applications
Typical issues include unclear intended purpose, incomplete manufacturer evidence, labelling gaps, and poor change control.
SaMD
Software as a medical device in Australia
Key planning questions for digital health, software functionality, intended use, evidence, and lifecycle updates.
UDI
Preparing for Australian UDI obligations
What manufacturers should begin organising across product identifiers, data ownership, and ARTG-linked records.
Quick glossary
Terms overseas manufacturers often ask about.
ARTG
The Australian Register of Therapeutic Goods. Medical devices generally need to be included before lawful supply in Australia, unless an exemption applies.
Australian Sponsor
The Australian-based entity responsible for TGA communication and key regulatory obligations for the supplied device.
Manufacturer evidence
Evidence that supports conformity assessment, quality system status, and the manufacturer's ability to supply compliant devices.
Post-market compliance
Ongoing activities after market entry, including reporting, change control, complaints, recalls, records, and audit readiness.