Forms & Application Links

Overview

Most TGA transactions — ARTG applications, adverse event reports, conformity assessment applications, and variation requests — are conducted through the TGA Business Services (TBS) portal. This is the central online platform for industry interactions with the TGA. You will need a TGA account to access TBS.

👉 TGA Business Services portal — TGA

Account and Access

Form / Portal	Purpose	Link
Create a TGA Business Services account	Required for all industry transactions	TGA
TGA eBusiness Services (eBS)	ARTG applications, variations, manufacturer evidence	TGA

ARTG Applications

Form / Portal	Purpose	Link
ARTG inclusion application (medical devices)	Apply to include a medical device in the ARTG	Via eBS portal
ARTG variation	Vary an existing ARTG entry	Via eBS portal
ARTG search	Search for devices currently in the ARTG	TGA ARTG search

Conformity Assessment

Form / Portal	Purpose	Link
TGA Conformity Assessment application	Apply for TGA-issued Conformity Assessment Certificate	Via eBS portal
Manufacturer evidence submission	Submit overseas regulator evidence as manufacturer evidence	Via eBS portal
EU MDR transition notification tool	Notify TGA of EU MDR transition for existing entries	TGA

Adverse Event Reporting

Form / Portal	Purpose	Link
IRIS — sponsor/manufacturer reporting	Report adverse events as a sponsor or manufacturer	TGA IRIS (industry)
IRIS — health professional reporting	Report adverse events as a health professional	TGA IRIS (health professional)
IRIS — consumer reporting	Report adverse events as a consumer	TGA IRIS (consumer)
ASDER — healthcare facility reporting	Report adverse events as a healthcare facility (from March 2025)	Contact MDAE.Support@health.gov.au
IRIS contact email	For urgent reports or assistance	IRIS@health.gov.au

Recalls and Market Actions

Form / Portal	Purpose	Link
Notify TGA of a potential recall	First step when a market action may be needed	recalls@tga.gov.au
DRAC database	Search current and historical market actions (recalls, alerts, corrections)	TGA DRAC
PRAC procedure	The current recall procedure (from March 2025)	TGA

Labelling and UDI

Form / Portal	Purpose	Link
AusUDID — UDI database	Australian UDI Database — submit and search UDI data	TGA AusUDID
Essential Principles Checklist	Downloadable EP compliance checklist template	TGA

Special Access

Form / Portal	Purpose	Link
SAS application (unapproved devices)	Apply for Special Access Scheme approval for an individual patient	TGA SAS
CTN notification	Notify TGA of a clinical trial under the CTN scheme	TGA CTN

Advertising Compliance

Form / Portal	Purpose	Link
Restricted representation approval	Apply for TGA approval to use a restricted representation	TGA
Report a non-compliant advertisement	Report potentially non-compliant therapeutic goods advertising	TGA
Advertising compliance checklist	Self-assessment tool for advertising compliance	TGA

SME Assist

Small businesses and new entrants to the Australian medical device market can access dedicated support through the TGA's SME Assist service. SME Assist provides tailored assistance, fee information, and regulatory guidance for small and medium enterprises.

👉 SME Assist — TGA

Overview​

Account and Access​

ARTG Applications​

Conformity Assessment​

Adverse Event Reporting​

Recalls and Market Actions​

Labelling and UDI​

Special Access​

Advertising Compliance​

SME Assist​

Related Pages​