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Manufacture of therapeutic goods
Manufacture of therapeutic goods is defined differently depending on the type of therapeutic goods:
- medicines, biologicals and other therapeutic goods
- medical devices.
Medicines, biologicals and other therapeutic goods
For medicines, biologicals and other therapeutic goods, manufacture includes, but is not limited to, any of the following:
- release for supply.
Section 3 of the Therapeutic Goods Act 1989 contains a full definition.
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:
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.