Dear members, TGA has released their enforcement priorities for 2026-2027, with Direct to consumer IVDs being No. 1 on the list and Software as a Medical Device being No. 7 of the twelve key areas that they intend to focus on.
The TGA releases compliance principles, reinforcing proactive and risk-based enforcement throughout 2026 and 2027
| The TGA Compliance Principles 2026 and 2027 outlines our strategic approach to monitoring and enforcing regulatory compliance for the import, export, manufacture, supply and advertising of therapeutic goods in Australia. |