Terms of Use

The information submitted on this site will be managed by the International Medical Device Regulators Forum (IMDRF), the Medical Devices Single Audit Program (MDSAP) and the Therapeutic Goods Administration (TGA), part of the Department of Health and Aged Care throughout the consultation process. 

By using this site, you accept these Terms of Use. If you do not agree with these terms, you must stop using the site immediately.

For the purpose of these Terms of Use:

  • ‘Terms’ or ‘Terms of Use’ means these terms and conditions, as amended by the TGA from time to time;
  • ‘We’ or ‘us’ means IMDRF, MDSAP and the TGA;
  • ‘You’ or ‘your’ means any person, persons, body, entity, or organisation that uses this site.

By accepting the Terms of Use, you understand and agree that:

  • any information you submit is true, accurate and complete;
  • your use of the site is solely for its intended purpose only;
  • your use must not interfere with the rights of others, including IMDRF, MDSAP or TGA;
  • you will not take any action that is illegal or unauthorised during your use; and
  • you will not transfer any harmful code.

You acknowledge and accept that:

  • To the fullest extent permitted by law, including but not limited to section 61A of the Therapeutic Goods Act 1989, the TGA will not be liable for any loss, damage, cost or expense incurred in or arising by reason of any person using or relying on this site, IMDRF or MDSAP;
  • Nothing in these Terms derogates from any other obligation you may have at law; or
  • These Terms are governed by the law in the Australian Capital Territory (ACT) and any dispute about these terms of the contents of this website are subject to the exclusive jurisdiction of the courts of the ACT.

Privacy and confidentiality

Where you are asked for personal information via any online form, this information will only be used for the purpose of conducting the stated exercise, and will not be used for any other purpose without your permission. On individual consultations, you may be offered the option to keep your response confidential. In the unlikely event your submission is published online, you will be given the option of withholding your personal details.

No personally identifiable information is stored within cookies used by this website. No attempt will be made to identify anonymous users unless required by law or required for the TGA’s functions. 

Visit the IMDRF Privacy Policy on IMDRF.org to read more about how IMDRF manage your privacy.

Visit the MDSAP Privacy Policy on MDSAP.global to read more about how MDSAP manage your privacy.

Disclaimer

This online response site is being hosted by an external company on behalf of IMDRF MDSAP and the TGA. You acknowledge and agree that we are not responsible for any part of the site, its services, any information or any functions that the external company is responsible for.

We undertake to maintain the accuracy of the information on this site relevant to IMDRF and MDSAP but we cannot accept responsibility for any loss, expense, cost or damage which may occur from relying on the information.

The material on this website may include the views or recommendations of third parties and does not necessarily reflect the views of the Australian Government or indicate a commitment to a particular course of action.

We cannot guarantee and assumes no legal liability or responsibility for the accuracy, currency, completeness or interpretation of the information on this website.

This website may contain links to other sites. We are not responsible for the actions (including any privacy practices or loss of information) of any third parties, We are also not responsible for the material contained in a website that is linked to this site. See our full disclaimer.

Copyright

Requests and inquiries concerning reproduction and rights are to be sent to the IMDRF Secretariat or the MDSAP RAC Secretariat.

You acknowledge that any use of this site does not, in any way, grant you any intellectual property rights. All rights are reserved.