Posts tagged with "Australia"

10. January 2020
With the announcement on "Therapeutic Goods Legislation Amendment" (2019 Measures No.1) the TGA informs about the intend to partially reform the existing legislation. What is addressed in this first package: Software (will be largely aligned with the EU MDR requirements) Personalised medical devices The amendment has an impact to the classification as well as to the Essential requirements. The details will be following early 2020.

01. December 2018
Australian TGA reclassifies the surgical mesh products from IIb to Class III

04. December 2017
The Australian Authorities published the new fees applicable to medical devices as of December 4th, 2017. The table with applicable fees is available on the TGA Website.

01. July 2017
Amendments to the existing regulations called "2017 Measures No.1" were published. The amendments are consolidated in the Compilation No. 32

02. February 2017
A new guidance on clinical evaluation is now available...