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About boundary and combination products
Combination products are therapeutic goods that combine elements of medicines, medical devices or biologicals.
Examples of combination products include:
pre-filled syringes
medicine-releasing stents.
Boundary products are therapeutic good that have attributes of two or more product types (medicine, medical device or biological).
Examples of boundary products include:
nasal decongestion products
eye lubricating products.
Unless exempt or excluded, these products must be listed, registered or included in the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully supplied in Australia.
You must ensure the products meet relevant manufacturing, safety, quality, efficacy and performance standards.
We assess applications (where required) and monitor post-market safety to protect public health in Australia. Understanding the classification and regulatory pathway helps sponsors comply with legal obligations.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to boundary and combination products. You may also have to meet obligations that apply to all products.