The Australian Medical Research and Innovation Strategy (Strategy) is determined by the Australian Medical Research Advisory Board (AMRAB). The current Strategy covers the period 2016-2021, with the next Strategy (2021-2026) to be registered before 8 November 2021. The Medical Research...More
Scheduling amendments referred to expert advisory committee
This pre-meeting 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 November 2021...More
Published in 2000, Australia’s National Medicines Policy (NMP) aims to deliver positive health outcomes for all Australians through their access to and appropriate use of medicines. It is a well-established and universally endorsed framework based on partnerships between consumers and all...More
The Therapeutic Goods (Excluded Goods) Determination 2018 provides that “household and personal aids, or furniture and utensils, for people with disabilities” are excluded goods, and so regulated as consumer products rather than therapeutic goods.
This exclusion of aids for...More
The Department of Health invites submissions in relation to proposed improvements to the Private Health Insurance (PHI) Prostheses List (PL). Consultation paper 1 concerns to the purpose, definitions and scope of the Prostheses List.
In the 2021-22 Federal Budget, the Australian...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 (films) and...More
ATTENTION: Due to difficulties many of our stakeholders are experiencing in lockdown, the closing date for submissions to this consultation has been extended until Wednesday 29th September 2021 . The outcomes of the consultation will now be anticipated for publication on Wednesday 15th...More
This form is to be 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.
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
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 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
Contracted Service Providers (providers) are responsible for ensuring compliance with the requirements of the Australian Government Hearing Services Program (the program). The 6 Month Check-in survey has been developed to assist new providers with understanding if they are currently meeting...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.
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
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
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 medical devices that administer medicines or biologicals by inhalation to Class IIa (low-medium risk) or Class IIb (medium-high risk), effective...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 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
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