Therapeutic Goods (Excluded Goods) Determination 2018

Information about how Clinical Decision Support System (CDSS) software is regulated, including when they are and are not exempt from inclusion on the ARTG.

This guidance describes the requirements for sunscreens (and their ingredients), that we regulate as therapeutic goods in Australia.

Guidance for manufacturers and sponsors of personalised medical devices, including health professionals. Learn what we mean by ‘specified articles’ and the difference between exempt vs excluded products.

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

Information to assist sponsors and manufacturers of products making antiviral claims determine if their product require an entry in the Australian Register of Therapeutic Goods (ARTG) to be legally imported and/or supplied in Australia.

This guidance will assist you in determining if a product is a cosmetic or a therapeutic good and how to comply with Australian regulatory requirements and advertising rules for therapeutic goods.

Guidance to help work out if your autologous HCT product is excluded from our regulation.

Guidance to determine the level of regulation of PRP, PRF or conditioned serum products for therapeutic use.

Guidance to help you understand which therapeutic goods will be regulated as a biological.

This guidance helps providers of digital mental health services or products to understand their regulatory obligations.

Guidance to help manufacturers of active medical devices, including software-based medical devices, to classify their devices.

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

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 the transitional arrangements and obligations.