Manufacture of therapeutic goods

29 April 2013

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:

  • 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.