General Requirements for Labels for Therapeutic Devices - Australian Government

Description

You must 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 either:

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

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

Service type

Code of Practice

A code of practice can be either a legal requirement or non-legal requirement. Legal codes of practice are defined as a result of legislation. Non-legal codes of practice are defined by industry regulators and bodies.

Act(s) name

Therapeutic Goods Act 1989 AG

Regulation(s) name

Therapeutic Goods Order No. 37 - General Requirements for Labels for Therapeutic Devices 1991 AG

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.

Enquiries

Therapeutic Goods Administration

Department of Health

Operating address: 136 Narrabundah Lane
Symonston
Australian Capital Territory 2609
Mailing address: TGA, PO Box 100
Woden
Australian Capital Territory 2606
Phone: 1800 020 653
Email: info@tga.gov.au