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

For sponsors who are providing their notification to the TGA of their Class 1-3 in-house IVDs.

Last updated

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
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