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.

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 the regulatory requirements for assessed listed medicines.

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

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

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.

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.

Manufacturers are responsible for maintaining scientific and engineering evidence that shows that their devices comply with the Essential Principles (the Principles).

Guidance to assist sponsors and manufacturers comply with Therapeutic Goods (Microbiological standards for medicines) (TGO 100) Order 2018.

Assists in the interpretation of the PIC/S GMP requirements when manufacturing compounded medicines

This guidance document provides information about when and how clinical decision support software is regulated in Australia by the TGA.

Guidance on requirements relating to impurities in prescription medicines entered in the Australian Register of Therapeutic Goods (ARTG).

This guidance is to assist you to apply for a Certificate of Free Sale or an Export Certificate for medical devices, including in-vitro diagnostic medical devices (IVDs) and Other Therapeutic Goods (OTGs).

Guidance on bioavailability and/or bioequivalence aspects of prescription medicines including information on biowaivers.

Guidance for manufacturers of medical or surgical face masks and respirators on the standards and key performance aspects required for inclusion on the Australian Register of Therapeutic Goods (ARTG).