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 and the Therapeutic Goods Regulations 1990 Therapeutic Goods (Medical provide that the ARTG has 3 parts, one relating to registrable Devices) Regulations 2002 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:
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:
devices-guidelines-35-150323.docx