Guidance

Learn the regulatory obligations for exempt medical devices in Australia, including manufacturer responsibilities, safety, record‑keeping and compliance requirements.

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

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

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

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

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

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

Guidance on reporting adverse events for sponsors of medical devices.

Guidance for importation, supply and wholesale requirements for medicinal cannabis.

Guidance about how to promote your business and service, without advertising biologicals to the public.

Guidance on the use of a medical device in a way that is not included in the intended purpose in the Australian Register of Therapeutic Goods (ARTG), and rules for advertising off-label uses.

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 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 preliminary assessment requirements for medical devices, including in-vitro diagnostics (IVDs), being included in the Australian Register of Therapeutic Goods (ARTG).

Guidance on when software is classified as an in vitro medical device and how it is regulated.

Guidance clarifying the interaction between our requirements and AHPRA advertising guidelines.

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