Blog
RSS FeedPosted by Michael Wonder on 22 Mar 2022
Hope for quadriplegics as ‘miracle treatment’ gets green light from regulator
21 March 2022 - In a major step forward for treating victims of paralysis, Australian regenerative medicine company Orthocell has ...
Posted by Michael Wonder on 04 Feb 2022
To hell and back: devices meant to ease pain are causing trauma
5 February 2022 - A $35,000 treatment at the forefront of medical technology which pumps electric pulses into the spine ...
Posted by Michael Wonder on 15 Sep 2021
Final report on the Australian Government response to the recommendations of the Senate Community Affairs References Committee Report
15 September 2021 - The Government acknowledges the efforts and actions detailed in this progress report to implement the Senate ...
Posted by Michael Wonder on 12 Aug 2021
Reclassification of software based medical devices
12 August 2021 - Recent changes to regulation of software based medical devices came into effect in early 2021, which ...
Posted by Michael Wonder on 05 Jul 2021
Medical devices reforms: enhancements to post-market monitoring
5 July 2021 - This project has been established to enhance the adverse event reporting processes. ...
Posted by Michael Wonder on 09 Jun 2021
Glaukos Announces Australia’s TGA regulatory approval for Preserflo MicroShunt
8 June 2021 - Glaukos Corporation today announced that the TGA has granted regulatory approval for the Preserflo MicroShunt intended for ...
Posted by Michael Wonder on 07 Jun 2021
Proposed refinements to the regulation of personalised medical devices
7 June 2021 - Regulatory changes introducing a new framework for the regulation of personalised medical devices commenced on 25 ...
Posted by Michael Wonder on 06 Oct 2020
PixCell Medical announces regulatory approval from Australian TGA for HemoScreen point of care hematology analyser
5 October 2020 - PixCell Medical announced today that it has received regulatory approval from the Australian TGA for the ...
Posted by Michael Wonder on 16 Aug 2020
Submissions received: scope of regulated software based medical devices
14 August 2020 - A total of 48 submissions were received in response to the Scope of Regulated Software based products ...
Posted by Michael Wonder on 23 Jul 2020
Delays to the commencement of certain medical device regulatory changes
23 July 2020 - The Governor-General in Council has made regulations which delay the commencement of a number of medical ...
Posted by Michael Wonder on 02 Jul 2020
Cochlear calls for low risk health apps to be exempt from TGA register
3 July 2020 - Hearing implant giant Cochlear has called for some low risk health apps to be exempt from ...
Posted by Michael Wonder on 02 Jul 2020
Reduced annual charges for medical devices listed on the prostheses list
2 July 2020 - In response to the suspension of elective surgery due to COVID-19 and the significant impact this has ...
Posted by Michael Wonder on 31 Mar 2020
Expedited COVID-19 medical device application process
31 March 2020 - The Therapeutic Goods Administration is currently undertaking an expedited assessment process for all medical devices associated with ...
Posted by Michael Wonder on 17 Mar 2020
Mass shipment of testing kits arrives as government pleads for supplies
17 March 2020 - The first shipment among 100,000 new coronavirus testing kits were due to arrive in Australia on ...
Posted by Michael Wonder on 19 Feb 2020
Medical device application processing times
19 February 2020 - Australia's regulatory framework for therapeutic goods is undergoing a number of changes in response to the Review ...