How to Submit a Custom-made Medical Device Notification: Step by Step Guide to Submitting a Custom-Made Medical Device (CMMD) Notification

Guide for Submitting Custom-Made and Patient-Matched Medical Device Notifications

This guide provides step-by-step instructions for submitting notifications for custom-made or patient-matched medical devices. Key points include:

• Client Identification Number: Instructions on obtaining a client ID number and accessing the TGA Business Services (TBS) online portal.
• Accessing the Form: The notification form can be accessed through the PMR compliance Dashboard or the TBS portal homepage.

Key Dates:

• Transition Notification Period for eligible patient-matched medical devices: until 01-Nov-2024.
• Deadline for Inclusion in the ARTG: 01-Jul-2029.

Notification Process:

• Complete the notification form and submit a formal declaration for your device.
• Notifications can be withdrawn or modified if necessary.

Resources and Assistance:

For general advice, contact the Medical Devices Information Unit or email PersonalisedDevices@health.gov.au for personalized medical device regulation assistance.

This guide ensures compliance with regulatory requirements for custom-made and patient-matched medical devices and provides resources to support the notification process.

Region: Australia

Source: https://www.tga.gov.au/resources/resource/guidance/how-submit-custom-made-medical-device-and-patient-matched-medical-device-notification