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Class 1-3 in-house IVD notification
[PDF, 443.21 KB]
Class 1-3 in-house IVD notification
[DOCX, 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