Therapeutic Goods Orders - Australian Government

Description

You may be required to comply with these orders if you are involved in the manufacturing or production of therapeutic goods, including biologicals and medical devices.

Therapeutic goods are broadly defined as products for use in humans in connection with:

  • preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury
  • influencing, inhibiting or modifying a physiological process
  • testing the susceptibility of persons to a disease or ailment
  • influencing, controlling or preventing contraception
  • testing for pregnancy.

This includes things that are:

  • used as an ingredient or component in the manufacture of therapeutic goods
  • used to replace or modify parts of the anatomy.

Please consult the Contact Officer for more information and to ascertain the level of compliance that may be required.

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

Therapeutic Goods Administration

Contact details

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

Please use these contact details for help or more information:

Enquiries

Therapeutic Goods Administration

Department of Health

Operating address: 136 Narrabundah Lane
Symonston, Australian Capital Territory 2609
Mailing address: PO BOX 100
Woden, Australian Capital Territory 2606
Toll Free: 1800 020 653
Email: info@tga.gov.au
Website: Therapeutic Goods Administration (Opens in new window)