Guidance

Guidance on how medical devices must comply with the Essential Principles, which set out fundamental safety and performance requirements.

Guidance for sponsors and manufacturers about regulatory requirements for exempt therapeutic goods.

This guidance applies to manufacturers of medical devices that are regulated as system or procedure packs and supplied using the special conformity assessment procedure regulatory pathway.

Guidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.

Guidance for sponsors on how and when to use a boxed warning in PI or a CMI.

Guidance on our risk-based approach and criteria for autologous human cell and tissue exemptions, exclusions and regulation.

This guidance supports psychiatrists in understanding their regulatory requirements when prescribing MDMA and psilocybine from 1 July 2023.

Guidance on how medical device labelling requirements help manufacturers and sponsors fulfil their responsibilities.

Guidance on how to meet regulatory requirements for the manufacture and supply of tampons in Australia.

Guidance on the documents that may be required to include a medical device in the Australian Register of Therapeutic Goods (ARTG), including In Vitro Diagnostic medical devices (IVDs).

Guidance for industry on how to apply for consent to supply therapeutic goods that do not comply with subsection 9(2) of TGO 92.

Australian Regulatory Guidelines for Biologicals (ARGB). This guidance will help you understand how to classify your biological.

Guidance on the requirements that specifically apply to active medical devices.

Guidance on how sterilants and disinfectants are regulated in Australia. List of relevant legislation.

Guidance relating to the supply of in vitro diagnostic medical devices for the detection of COVID-19/SARS-CoV-2 infections.

Guidance for sponsors of antibiotics on collecting and providing pre- and post-market information about antibiotic resistance.

Guidance on equivalence of herbal extracts in complementary medicines.

Guidance for preparing and submitting an application for inclusion of a Class 1 biological on the ARTG.

If your business is involved with medicinal cannabis products or health services involving medicinal cannabis, this guidance will help ensure you do not unlawfully advertise medicinal cannabis to consumers. This includes through the promotion of your business or services.

Guidance on the rules governing COVID-19 rapid antigen tests (RATs) advertising.

Guidance on advertising services that involve therapeutic goods.

Guidance for sponsors of certain medical devices who are required to submit annual reports.

Guidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.

Guidance for new sponsors on how to supply, import, and export disinfectant products.

Guidance on reporting adverse events for sponsors of medical devices.