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Class 1-3 in-house IVDs: using the online application form

Last updated

8 May 2024

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

Additional information

Manufacturing or supplying in-house in-vitro diagnostic medical devices (IVDs)

14 October 2024

Guidance

Guidance explaining regulatory requirements for in-house in-vitro diagnostic medical devices (IVDs).

Supporting documents

In-house IVD notification template [Excel, 15.94 KB]

Topics