Submission to the Therapeutic Goods Administration's Consultation: Scope of regulated software based products

Last updated 17 August 2020


Date: 15 May  2020

The RACGP has responded to the proposed amendments within the Migration Amendment (Prohibiting

The RACGP provided written comment to Therapeutic Goods Administration's (TGA) consultation 'Scope of regulated software based products'. The submission addresses:

  1. Exclusion of general practice clinical information systems from regulation by the TGA
  2. Exclusion or exemption criteria for clinical decision support