Guidance

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 reporting adverse events for sponsors of medical devices.

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

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

Guidance to assist sponsors and manufacturers of medicinal cannabis products to conform with TGO 100.

From 1 March 2024, a sponsor notice must be given by a sponsor of a vaping good to the TGA before the good is imported into, or supplied in, Australia following domestic manufacture.

Guidance on the use of market authorisation evidence from comparable overseas regulators for medical device applications.

Guidance on interpretation of software exclusion criteria to understand the boundaries between software that is and is not regulated.

Guidance about regulatory changes for software based medical devices, including software as a medical device (SaMD).

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

This guidance helps Australian health practitioners, that manufacture, supply, and use medical devices, to understand whether you are regulated by us, and how to comply.

Guidance on regulatory requirements for Ahpra registered dental practitioners making and adapting personalised medical devices for patients.

Guidance on the transitional arrangements and obligations.

Guidance on the transitional arrangements and obligations of sponsors and manufacturers.

Guidance for sponsors of medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS) on transitional arrangements and obligations.

Guidance to assist sponsors of medical devices that administer medicines or biologicals by inhalation meet their obligations and comply with regulations

Guidance about how to apply for a permit to export human substances under the Customs (Prohibited Exports) Regulations 1958.

Guidance on the format requirements for dossiers.

Guidance to assist sponsors and manufacturers when applying for inclusion in the Australian Register of Therapeutic Goods (ARTG) and selecting a GMDN term.

Guidance about how we define and regulate listed disinfectants, including how to submit a product application and the supporting data and other information required.

This guidance is for sponsors applying for a variation to the Australian Register of Therapeutic Goods (ARTG) entry of a biological

Guidance explaining types of variations, for registered medicines and biologicals, that can be submitted as notifications due to being very low risk.

This guidance aims to assist sponsors of active implantable medical devices (AIMD) with meeting their obligations.