Manufacture of therapeutic goods

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.