On 14 August 2020, the Hon Mark Coulton, Minister for Regional Health, Regional Communications and Local Government, announced a review into the Hearing Services Program.
An Independent Expert Panel comprising Professor Mike Woods (Chair) and Dr Zena Burgess is conducting the Review. The...More
There are currently three medicines available for the treatment of opioid dependence under the Pharmaceutical Benefits Scheme (PBS)
Opiate Dependence Treatment Program (ODTP). These medicines are buprenorphine (tablets and modified release injections), buprenorphine with naloxone...More
The Australian Government has a clear and bold vision for sport integrity in Australia, and is committed to ensuring Australian sport is appropriately protected in the rapidly evolving sports integrity threat environment .
The reforms announced as part of this package will require...More
The Efficient Funding of Chemotherapy (EFC) Program provides funding for chemotherapy medicines used for the treatment of cancer that are administered through infusion or injection at public or private hospitals. Not all chemotherapy medicines are provided through the EFC Program, but may be...More
The Therapeutic Goods Administration (TGA) is seeking feedback on a proposal to remake some of the legislative instruments relating to human cell and tissue (HCT) products (including blood and blood components), which sunset in October 2021.
We are seeking feedback to make sure the...More
On 25 February 2021, changes to the Therapeutic Goods (Medical Devices) Regulations 2002 (‘the Regulations’) commenced to introduce a new regulatory framework (the Framework) for medical devices that are designed and manufactured for individual patients (otherwise known as 'personalised'...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
This form should be used by sponsors and manufacturers of software-based medical devices that will need to be included in the ARTG at a higher classification as a result of the amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 from 25 February 2021. Devices are eligible for...More
From 25 February 2021, a new framework for regulating personalised medical devices will commence. Comprehensive guidance about the framework can be found at: https://www.tga.gov.au/resource/personalised-medical-devices-including-3d-printed-devices
The Therapeutic Goods...More
This form should be used by manufacturers and sponsors of medical devices that record patient images or that are anatomical models, and that will be reclassified by the amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 from 25 February 2021. Devices are eligible for...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
From 19 October 2020, how the TGA engages with the sponsors for post market reviews has changed. A new medical device Post Market Review Compliance Dashboard has been developed in TBS to respond to post market reviews. The new compliance dashboard will provide the sponsors with an efficient...More
The Department of Health administers the Australian Government Hearing Services Program (the program). The program supports the delivery of hearing services to over one million eligible clients through Contracted Service Providers.
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This form is to completed if you wish to complete a request for a revalidated service for a client with the Australian Government Hearing Services Program.
Please click the link below to begin your request.
DISCLAIMER
This is a draft form for testing purposes only. The form...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 risk), effective...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.
From 25 November...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 that determines the patient management from Class IIa (low-medium risk)/Class IIb...More
Thank you for your interest in becoming accredited as a service provider for the Australian Government Hearing Services Program.
Please click the link below to begin your application.
You may wish to download a PDF of the application form for your information before you proceed....More
Thank you for your interest in becoming registered as an Appointed Supplier for the Australian Government Hearing Services Program.
Please click the link below to begin your application.
You may wish to download a PDF version of the application form before you proceed. Note that we...More
Thank you for your interest in transferring your accreditation as a service provider for the Australian Government Hearing Services Program to another entity.
Please click the link below to begin your application.
You may wish to download a PDF of the application form for your...More
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