New TGA Guide for Submitting a CMMD Notification

TGA has released a new update on how to submit a Custom-Made Medical Device (CMMD) notification. This new guidance is intended for manufacturers and sponsors who manufacture, supply, or import CMMDs.

What Does the New TGA CMMD Guide Do?

The new guide is designed to facilitate the process of completing and submitting notifications for Custom-Made Medical Devices. The notification form on the new database takes about ten minutes to complete, replacing the previous system. Notifications submitted on the old database before it ceased in August 2022 remain valid but cannot be transferred to the new system. Manufacturers and sponsors who previously notified CMMDs on the business.gov.au site are advised to resubmit their notifications to the new database. This will allow them to view, modify, and withdraw their submissions, as well as receive improved support and updates.

What Should Manufacturers and Sponsors of CMMDs Do?

Manufacturers and sponsors of CMMDs must notify the TGA within two months of manufacturing or first supplying a CMMD. Although custom-made medical devices are exempt from inclusion in the ARTG, they are still regulated and must meet TGA requirements, including compliance with the Essential Principles, adherence to advertising regulations, submission of annual reports, and reporting of adverse events.

To submit a CMMD notification, a client ID is required. Once registered as a TGA client with a TBS account, the notification form can be accessed either directly through the PMR Compliance Dashboard or from the TGA Business Services Portal homepage. The form may be submitted by either the manufacturer or the sponsor.

Read more about how to submit a TGA CMMD notification here.

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If you’re interested in learning more about submitting a Custom-Made Medical Device (CMMD) notification, visit the TGA’s step-by-step guide for detailed instructions. For further assistance, feel free to contact us directly. Our team is here to help you navigate the requirements and answer any questions you may have about the notification process.

Learn how MedEnvoy can assist you:

• • • Australian TGA Sponsor
    • RA Consulting
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