The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Class 1-3 in-house IVD notification
[PDF, 443.21 KB]
Class 1-3 in-house IVD notification
[Word, 1.19 MB]
This guidance is for sponsors who are providing their notification to the TGA of their Class 1-3 in-house IVDs.
Changes to the previous version
- Consolidation of web pages to include information previously on Updating an existing Class 1-3 in-house IVD notification
- Updated instructions on how to complete the in-house IVD notification form and template
- Additional information about the In-house IVD notification template