Australian Regulatory Guidelines for Medical Devices (ARGMD) - Australian Government

Service summary

You may be required to comply with these guidelines if you intend to manufacture medical devices in Australia for the Australian market or for export to overseas markets, or if you manufacture medical devices overseas for import into the Australian market.

The guidelines provide details about the classes of medical devices, safety, risks, performance and the clinical evidence needed to support the application for the inclusion of a medical device on the Australian Register of Therapeutic Goods.

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.

Administering agency

Department of Health
Therapeutic Goods Administration

Act(s) name

Therapeutic Goods Act 1989 (Australian Government)

Regulation(s) name

Therapeutic Goods Regulations 1990 (Australian Government)

Contact details

Information Officer
Department of Health
Therapeutic Goods Administration


Operating address:
136 Narrabundah Lane
Symonston
Australian Capital Territory 2609
Mailing address:
PO Box 100
Woden
Australian Capital Territory 2606

Phone:

02 62328644

Phone:

1800020653

Fax:

02 62031605
info@tga.gov.au

Supporting information

Disclaimer

The information contained on the Australian Business Licence and Information Service (ABLIS) web site, or via packages or other sources is intended for general guidance only.

To the full extent permitted by law, the Federal, State, Territory and Local Governments make no representations or warranties (expressed or implied) in relation to the information, including its accuracy, currency or completeness.

The business information provided does not constitute professional or legal advice, nor is the use of any third party resource an endorsement of the information contained, the associated organisation, product or service. It is recommended that you obtain appropriate professional and /or independent legal advice to ensure that the material provided here is relevant to your particular circumstances.

To the full extent permitted by law the Federal, State, Territory and Local Governments, their employees and agents do not accept any liability for any reason, including without limitation, liability in negligence, to any person for the general information which is provided herein, or in respect of anything, including the consequences of anything done, or not done, by any such person in whole or partial reliance upon the information.