You are here Home How we regulate Manufacturing 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 Loading... Medicines, biologicals and other therapeutic goodsFor medicines, biologicals and other therapeutic goods, manufacture includes, but is not limited to, any of the following:productionprocessingassemblingpackaginglabellingstoragesterilisingtestingrelease for supply.Section 3 of the Therapeutic Goods Act 1989 - external site contains a full definition. Medical devicesFor 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:assemblingpackagingprocessingrefurbishinglabelling.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 devicethe instructions for using the deviceany advertising material relating to the devicetechnical documentation describing the mechanism of action of the device.Section 41BG in Part 4-1 Division 2 of the Therapeutic Goods Act 1989 - external site contains a full definition. Topics Manufacturing Main navigation