alcohol swab (with antiseptic Medicine …… alcohol swab (with no claims other than cleaning the skin) Medical Device ……………………… fabric dressing with antiseptic Medicine/Medical …………. Device (dependent on manufacturer’s intended purpose) toothpaste scheduled or with therapeutic claims (SUSDP Medicine beyond permitted oral hygiene claims) toothpaste other Not Therapeutic Good ………………………. tooth whitener Excluded ………………………. THERAPEUTIC STATUS FOR ARTG PURPOSES contact lens cleaning solutions Medical Device ……….. sterilants (except sterilant gases) for use on medical devices Medical Device ……………………… 25. Antiseptics, disinfectants, cleaners, soaking solutions: instrument grade disinfectants Medical Device ……….. hospital grade disinfectants with specific claims* Therapeutic Device (Registrable) household/commercial grade with specific claims* Therapeutic Device (Registrable) hospital grade disinfectants with non-specific claims* Therapeutic Device (Listable) household/commercial grade disinfectants with non-specific claims* Therapeutic Device (Exempt) ………………… ostomy appliance detergents, deodorisers Not Therapeutic Good cleaners and sanitisers not making disinfectant claims Not Therapeutic Good * to Therapeutic Goods Order No. 54/54A & Guidelines - Standard for composition, packaging, labelling and performance of disinfectants and sterilants Specific claim in relation to disinfectants - Is a claim which covers virucidal, sporicidal, tuberculocidal, fungicidal or other biocidal activity. Except where claims of activity against fungi (yeast and mould) for excluded products are concerned, such claims lift a product into the registrable category of goods. Non-specific claim in relation to disinfectants - Is a claim which includes general antibacterial action or activity against bacteria covered by the battery of test organisms included in the specified test, or bacteria of the same family. Claims for bacteria other than these are allowable and do not cause the product to become registrable, but the specific organism against which activity is
alcohol swab (with antiseptic …… Medicine alcohol swab (with no claims other than cleaning the skin) ……………………… Medical Device fabric dressing with antiseptic …………. Medicine/Medical Device (dependent on manufacturer’s intended purpose) toothpaste (SUSDP scheduled or with therapeutic claims beyond permitted oral hygiene claims) Medicine toothpaste other ………………………. Not Therapeutic Good tooth whitener ………………………. Excluded THERAPEUTIC STATUS FOR ARTG PURPOSES contact lens cleaning solutions ……….. Medical Device sterilants (except sterilant gases) for use on medical devices ……………………… Medical Device 25. Antiseptics, disinfectants, cleaners, soaking solutions: instrument grade disinfectants ……….. Medical Device hospital grade disinfectants with specific claims* Therapeutic Device (Registrable) household/commercial grade with specific claims* Therapeutic Device (Registrable) hospital grade disinfectants with non-specific claims* Therapeutic Device (Listable) household/commercial grade disinfectants with non-specific claims* ………………… Therapeutic Device (Exempt) ostomy appliance detergents, deodorisers Not Therapeutic Good cleaners and sanitisers not making disinfectant claims Not Therapeutic Good * to Therapeutic Goods Order No. 54/54A & Guidelines - Standard for composition, packaging, labelling and performance of disinfectants and sterilants Specific claim in relation to disinfectants - Is a claim which covers virucidal, sporicidal, tuberculocidal, fungicidal or other biocidal activity. Except where claims of activity against fungi (yeast and mould) for excluded products are concerned, such claims lift a product into the registrable category of goods. Non-specific claim in relation to disinfectants - Is a claim which includes general antibacterial action or activity against bacteria covered by the battery of test organisms included in the specified test, or bacteria of the same family. Claims for bacteria other than these are allowable and do not cause the product to become registrable, but the specific organism against which activity is
devices-guidelines-35-150323.docx