General Requirements for Labels for Therapeutic Devices - Australian Government


You may need to comply with these requirements if you are involved in the manufacture and preparation of therapeutic devices. You will only be required to comply if you are involved in the part of the process where a label is placed on the device.

There are certain exemptions. You will not need to comply with these requirements if the device:

  • is a sterile therapeutic device (there are separate standards for sterile devices)
  • is a non-sterile implantable device
  • is manufactured and supplied for use to an individual
  • is intended for dental use and is not implanted directly into bone or soft tissue
  • is intended for veterinary use
  • is for in vitro use
  • is intended solely for export from Australia
  • is for the purpose of conducting clinical trials.

Service type

Code of Practice

A code of practice is a set of rules which details how people in a certain industry should behave. A code of practice can be defined as a result of legislation or by industry regulators and bodies.

Act(s) name

Therapeutic Goods Act 1989 Australian Government

Regulation(s) name

Therapeutic Goods Regulations 1990 Australian Government

Administering agency

Department of Health and Aged Care

Therapeutic Goods Administration

Contact details

Contact Email, Phone and Address Details for this service in simple two column table format, header then data.