You are here Home Manufacture of therapeutic goods Manufacture of therapeutic goods is defined differently depending on the type of therapeutic goods. Last updated 29 April 2013 Listen Print Share LinkedIn (Twitter) Facebook Email Loading... Medicines, biologicals and other therapeutic goods For medicines, biologicals and other therapeutic goods, manufacture includes, but is not limited to, any of the following: production processing assembling packaging labelling storage sterilising testing release for supply. Section 3 of the Therapeutic Goods Act 1989 contains a full definition. Medical devices For medical devices, the manufacturer refers to the original owner of the product, or an agent acting on their behalf. A manufacturer of a medical device may be involved in one or more of the following activities: assembling packaging processing refurbishing labelling. The manufacturer assigns the device its purpose by means of information supplied in any one or more of the following ways: the labelling on the device the instructions for using the device any advertising material relating to the device technical documentation describing the mechanism of action of the device. Section 41BG in Part 4-1 Division 2 of the Therapeutic Goods Act 1989 contains a full definition. Topics Manufacturing