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Overview & Process

Overview​

The Australian Register of Therapeutic Goods (ARTG) is the national register of all therapeutic goods approved for supply in Australia. Inclusion in the ARTG is the point at which a medical device is formally authorised for supply. Only the Australian sponsor can apply for ARTG inclusion — manufacturers cannot apply directly. The process is managed through the TGA's eBusiness Services (eBS) portal, and the requirements, fees, and audit likelihood vary significantly by device class.

The Inclusion Process — Step by Step​

Step 1 — Confirm classification Before applying, confirm the correct device class under Schedule 2 (general devices) or Schedule 2A (IVDs). The classification must be supported by documented rationale in the technical file.

Step 2 — Obtain manufacturer evidence For Class IIa and above: ensure the manufacturer's conformity assessment evidence has been submitted to and accepted by the TGA before lodging the ARTG application. For Class I and Class 1 IVDs, evidence is submitted with the application.

Step 3 — Prepare the application Using the TGA's eBS portal, prepare the application including:

  • Device description and intended purpose
  • Manufacturer details
  • Classification and conformity assessment evidence references
  • Labelling information
  • Device nomenclature codes (GMDN or equivalent)
  • Application fee payment

Step 4 — Submit the application Submit through eBS. The TGA will acknowledge receipt and begin preliminary assessment.

Step 5 — Preliminary assessment The TGA reviews the application to confirm it meets minimum requirements (correct class, required evidence documents present, fees paid). Applications that fail preliminary assessment are rejected. No refund of the application fee is provided.

Step 6 — Audit (if selected) Applications may be selected for audit. During an audit, the TGA requests additional documentation and reviews it against Australian regulatory requirements. Responding promptly and thoroughly to audit requests reduces delays.

Step 7 — Inclusion decision If the application passes preliminary assessment (and any audit), the TGA includes the device in the ARTG and issues an ARTG entry number. The device can then be legally supplied in Australia.

Passing Preliminary Assessment​

Preliminary assessment is a structured check that the application meets minimum requirements. Common reasons applications fail preliminary assessment include:

  • Wrong device class selected
  • Manufacturer evidence not yet accepted or not matching the device type
  • Missing or outdated conformity assessment documents
  • Incomplete labelling information
  • Device description inconsistent with the approved intended purpose

Failing preliminary assessment results in rejection — the application fee is not refunded. Sponsors should thoroughly check the application against TGA requirements before submitting.

👉 Passing preliminary assessment — TGA guidance

ARTG Entry Details​

An ARTG entry is specific to the combination of:

  • Sponsor
  • Manufacturer
  • Kind of device (defined by intended purpose, classification, and characteristics)

Each unique combination requires its own ARTG entry. If a sponsor changes, a new application is required. If the manufacturer changes, a new application is required. Multiple models or variants of the same device may be included within a single ARTG entry if they share the same intended purpose, classification, and manufacturer — but the TGA's guidance on what constitutes the same "kind" of device should be reviewed.

Official Sources​