Guidance

Understand the regulatory requirements for supplying UDI compliant medical devices in Australia

Timeframes for supplying UDI compliant medical devices in Australia

Guidance on GCP inspections for clinical trial sites of investigational biologicals, medicines and medical devices regulated under the Clinical Trial Notification (CTN) or Clinical Trial Approval (CTA) schemes.

Guidance to help you understand requirements for disease information and advertising.

This guidance explains the new regulatory requirements for medical devices containing medicinal, microbial, recombinant, or animal origin substances effective from 1 July 2024. It helps sponsors interpret the new classification rule, conformity assessment requirements and transition arrangements.

Guidance for sponsors and manufacturers to meet the technical, scientific and regulatory requirements to ensure the quality of probiotic medicine acceptable under the Therapeutic Goods Act 1989

This Guidance explains how overseas assessments can support our medical device certification and registration processes.

This guidance is to help sponsors and manufacturers of in-vitro diagnostic (IVD) medical devices transition to new manufacturer evidence requirements.

Guidance for sponsors who have submitted applications for inclusion of medical devices including in-vitro diagnostics (IVDs), in the Australian Register of Therapeutic Goods (ARTG).

Guidance to help sponsors and manufacturers of medicines meet the Australian labelling requirements in TGO 91 and TGO 92.

Guidance on how to apply to register a biosimilar medicine on the Australian Register of Therapeutic Goods (ARTG) and ongoing sponsor responsibilities.

Guidance to help sponsors understand the potential overlap between certain foods, medicines, devices and cosmetics.

Guidance on dossier information required for registered complementary medicine applications, to be consistent with the Common Technical Document (CTD) format.

Guidance on the regulatory requirements for assessed listed medicines.

Guidance explaining the regulatory requirements for listed medicines and how we undertake compliance reviews.

The requirements for an effective OTC medicines application commences 1 March 2016.

Guidance providing an overview of listed medicines and listed assessed medicines pathways and legislative requirements.

Guidance for manufacturers and sponsors on shoulder, hip and knee joint replacement medical devices and ancillary medical devices.

Administrative information to support OTC medicine applications in Australia

These requirements apply to applications for the addition of new ingredients, or variation of existing ingredients, as listed in the Permissible Ingredients Determination, that are lodged with the TGA from 1 February 2023.

Guidance for hand sanitiser manufacturers, suppliers and advertisers about meeting their regulatory obligations.

Guidance to help sponsors figure out if their therapeutic goods are medicines, biologicals, or medical devices.

Guidance about the administrative information to support assessed listed medicine applications.

Detailed guidance for exempt Clinical Decision Support Software (CDSS) which complements the general guidance already published.

Guidance for using the 'TGA assessed' claim on labels for assessed listed medicines and registered complementary medicines.