scratch test Medicine ……………………... patch Medicine (Exempt) …………………………… Antiseptics, disinfectants, cleaners, soaking solutions: antiseptics and skin disinfectants Medicine ………. antiseptic 'wipe' Medicine ………………………... tissue with: antiseptic Medicine ………………………….. viricide Medicine ……………………….…… 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 GOODS 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 * Refer 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
scratch test ……………………... Medicine patch …………………………… Medicine (Exempt) Antiseptics, disinfectants, cleaners, soaking solutions: antiseptics and skin disinfectants ………. Medicine antiseptic 'wipe' ………………………... Medicine tissue with: antiseptic ………………………….. Medicine viricide ……………………….…… Medicine 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 GOODS 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 * Refer 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
devices-guidelines-35.docx