Notification form: Lapses in medical device conformity assessment certification

Closes 22 Jul 2026

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Documents Upload

On this page you can attach required supporting documents to the form. Please ensure the documents uploaded are either in Adobe PDF, Microsoft Word or Excel formats. Forms submitted without required documents may not be considered as valid notification by the TGA.  

1. For the ARTG entry/entries included in this form, upload documents related to non-conformities found in the last audit - if any.

Document 1

Please make sure your file is under 25MB

Document 2

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Document 3

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Document 4

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Document 5

Please make sure your file is under 25MB
2. Upload evidence if any other regulator has approved continued supply of the device(s) during lapsed conformity assessment certification.

Evidence - 1

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Evidence - 2

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Please make sure your file is under 25MB
3. Upload any other supporting documentation to help the TGA assess this notification.

Supporting document 1

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Supporting document 2

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Supporting document 3

Please make sure your file is under 25MB