Guidance

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

Timeframes for supplying UDI compliant medical devices in Australia

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

This guidance describes options for the removal of the Product Information (PI) as an insert from a medicine package while still complying with the labelling order.

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 the regulatory requirements for assessed listed medicines.

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

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

Guidance explaining the post-market surveillance of 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.

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

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.

Guidance for sponsors on the fees payable and timeframes for different types of prescription medicine applications.

Guidance on how to provide the required patient information materials with all implantable and active implantable medical devices.

Australian regulatory guidelines for over-the-counter medicines (ARGOM) Appendix 3.

Australian regulatory guidelines for over-the-counter medicines (ARGOM) Appendix 4.

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

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