How to submit a custom-made medical device / patient-matched medical device notification v2.0

This document describes how to complete and submit custom-made medical device (CMMD) and patient-matched medical device (PMMD) transition notifications.

It is for manufacturers and sponsors who:

· make, supply or import CMMDs

· make or supply PMMDs supplied on or before 25 February 2021 and want these devices to be included in the Australian Register of Therapeutic Goods.

Main sections:

· Who needs to submit a CMMD notification

· Who needs to submit a PMMD notification

· Step 1: Getting started with the TGA

· Step 2: Access to the notification form

· Step 3: Submitting your CMMD Notification

· Step 4: After you have submitted a notification

· Further information and resources