therapeutic that are represented to achieve, or are likely to achieve, their principal intended action by pharmacological, chemical, immunological or metabolic means in or on the body of a human or animal; and any other therapeutic goods declared by the Secretary, by a notice published in the Gazette, not to be medical devices. Registrable, listable or included goods The Act, the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002 provide that the ARTG has 3 parts, one relating to registrable goods, one relating to listable goods and the other relating to included medical devices. Registrable and listable goods, including therapeutic devices, are regulated under Chapter 3 of the Act. Registrable goods undergo a more rigorous evaluation of their quality, safety and efficacy, before being entered into the ARTG, than listable therapeutic devices. Medical devices are regulated under Chapter 4 of the Act and can be included in the ARTG if they comply with the essential principles, have undergone an appropriate conformity assessment procedure and certain other requirements are complied with. Exemptions from the registration and listing provisions of the regulations are published in Schedules 5 and 5A of the Therapeutic Regulations (exempt goods). Excluded goods Goods may be declared by the Secretary, by Order published in the Gazette, to be or not to be therapeutic goods and thereby excluded from the jurisdiction of the Act. These products are detailed in the Therapeutic Goods (Excluded Goods) Order No 1 of 1998 was gazetted in the of 25 February 1998 and effective from the date of gazettal. An amended Order (No 2 of 1998) was signed on 12 March 1998 and was gazetted in GN 12 of 25 March 1998. This Order is currently undergoing review and, when finalised the new Order will be available on the TGA website as per the above address. THERAPEUTIC GOODS STATUS FOR ARTG PURPOSES Absorbable, with shape, used in surgery: sutures …….………………………………………… Medical Device staples ………………………………………………. Medical Device bone fixation devices ………………………………... Medical Device sponges ……………………………………………... Medical Device tissue adhesives (may include fibrin adhesives) .. Medical Device Absorbable, without shape, used in surgery:
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