Standard for Diagnostic Goods of Human Origin - Australian Government

Service summary

You must comply with this standard if you are involved in the preparation of goods which contain materials of human origin and are intended as laboratory reagents for diagnostic tests.

You are exempt from complying with this licence if the goods prepared:

  • Have been heat treated at 60 degrees C for 10 hours; or
  • Cannot be prepared from material that is non-reactive when testing for hepatitis B virus or antibody to HIV.

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 Order No. 34 - Standard for Diagnostic Goods of Human Origin 1990 (Australian Government)

Contact details

Enquiries
Department of Health
Therapeutic Goods Administration


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

Phone:

1800020653
info@tga.gov.au

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.