This notification form is for Australian manufacturers or sponsors of clinical decision support software, that meet the exemption criteria outlined in the Therapeutic Goods (Medical Devices) Regulations 2002 .
The exemption applies to medical devices that are clinical...More
From 1 December 2021, the application for consent to import, supply, or export a medical device that does not comply with the Essential Principles has moved to the TGA Business Services (TBS) portal. The new form will provide stakeholders with a more efficient way of submitting an application to...More
This form should be used by medical device manufacturers and sponsors that wish to access the transition period for patient-matched medical devices.
Please note: This form is being hosted on a consultation platform, however it is not a consultation and none of the information that you...More
The Australian Government is undertaking a significant program to reform the regulation of therapeutic goods in Australia. As part of the Australian Government Department of Health, the Therapeutic Goods Administration (TGA) regulates therapeutic goods, and is responsible for implementing the...More
Scheduling amendments referred to expert advisory committee
This consultation is for applications and delegate initiated proposals to amend the Poisons Standard. The scheduling amendments and any submissions received will be considered at the June 2022 meetings of the ...More
The Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 was made on 12 December 2019 to include the reclassification of active medical devices for therapy with a diagnostic function from Class IIa (low-medium risk)/Class IIb (medium-high risk) to...More
The Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 was made on 12 December 2019 to include the reclassification of active implantable medical devices (AIMD) from Class AIMD to Class III (high risk), effective from 25 November 2021.
...More
The Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 was made on 12 December 2019, to include the reclassification of medical devices composed of substances that are intended to be introduced into the human body through a body orifice or applied...More
The Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 was made on 12 December 2019 to include the reclassification of all surgically invasive medical devices intended to be used in direct contact with the heart, central circulatory system (CCS)...More
The Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 was made on 12 December 2019 to include the reclassification of medical devices that administer medicines or biologicals by inhalation to Class IIa (low-medium risk) or Class IIb (medium-high...More
The Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 was made on 12 December 2019 to include the reclassification of some spinal implantable medical devices. from Class IIb (medium-high risk) to Class III (high risk), effective from 25...More