Would the proposed health technology involve the use of a medical device, in-vitro diagnostic test, radioactive tracer or any other type of therapeutic good?
This information will reiterate answers you have provided under other questions, but we need that information briefly summarised here. This summary will enable the Department to identify if the TGA needs to be contacted (to confirm regulatory status of a particular therapeutic good(s) associated with the MSAC application).
Has it been listed or registered or included in the Australian Register of Therapeutic Goods (ARTG) by the Therapeutic Goods Administration (TGA)?
If applicable, please state the ARTG ID, TGA approved indication(s) and TGA approved purposes(s).
Is the therapeutic good classified by the TGA as either a Class III or Active Implantable Medical Device (AIMD) against the TGA regulatory scheme for devices?
Medical devices, diagnostic kits or pharmaceutical products may require TGA approval before they can be used in Australia. Please provide relevant details in relation to regulatory requirements.
For more information on these classifications, please see the information on the TGA website.
Is the intended purpose in this application the same as the intended purpose of the ARTG listing(s)?
Does the TGA approved indication or the indication for which TGA approval will be sought, align with the request for funding in this application
Is the therapeutic good to be used in the service exempt from the regulatory requirements of the Therapeutic Goods Act 1989?
If there is an exemption, please provide supporting documentation as an attachment to your Application Form, regarding the nature of the exemption.
Is the therapeutic good classified by the TGA as for Research Use Only (RUO)?
Indicate whether the therapeutic good classified is for Research Use Only (i.e., where there is no reporting of patient/client results).
Is the therapeutic good in the process of being considered for inclusion by the TGA?
If the therapeutic good is in the process of being considered by TGA, please provide the TGA Application ID and date of submission to the TGA.
Need further support?
If you have any questions or feedback, please contact HPP.support@health.gov.au