Australia announces to partially moderne the Regulations

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.