You may be required to comply with this standard if you intend to import or manufacture therapeutic devices with pyrogen and endotoxin content. Therapeutic devices to which this standard applies include all sterile therapeutic devices which are intended for contact, directly or indirectly, with the cardiovascular system, the lymphatic system or the cerebrospinal fluid and nervous system.
Please note that the Agency has advised that the schedule specifying what therapeutic devices are included corresponds with current international opinion and requirements. It is subject to ongoing review and may be amended from time to time.
Please consult the Contact Officer for more information and to ascertain the level of compliance (if any) that may be required.
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.
Department of Health
Therapeutic Goods Administration
Therapeutic Goods Act 1989 (Australian Government)
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
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