Updated Guidance – System or Procedure Packs
The Therapeutic Goods Administration (TGA) has refined its guidance on system or procedure packs (SOPPs) as of January 2024. This revision builds on the foundational document relea
Guidance on the vigilance system for CE-marked devices and the Device Specific Vigilance Guidance (DSVG) Template
This newsletter is aimed toward introducing the Device Specific Vigilance Guidance (DSVG), a pivotal document aimed at harmonsing vigilance reporting and offering comprehensive gui
TGA Fees and Charges Proposal 2024-25
The Therapeutic Goods Administration (TGA) is seeking feedback on its proposed fees and charges for the 2024-25 financial year. This consultation allows stakeholders to comment on