Personalised medical devices update
Date published:
19 Aug 2022
The Therapeutic Goods Administration (TGA) has issued guidance on how to use the new, improved custom-made medical device database.
This new database has been developed for manufacturers and sponsors to notify the TGA of:
- the manufacture, supply or import of a kind of custom-made medical device; and/or
- your intention to access the transition arrangement for a patient-matched medical device that needs to transition to inclusion in the Australian Register of Therapeutic Goods (ARTG)
This new database is hosted on the TGA’s eBusiness (TBS) website and replaces the two separate databases previously used to notify the TGA of custom-made and patient-matched medical devices.
Frequently Asked Questions
Why is there a new custom-made medical device database?
The new database responds to feedback from stakeholders asking for improvements. The TGA has introduced new functions to support our clients, which means you will be able to:
- view all of your previously submitted notifications
- edit or modify information about your devices
- withdraw notifications that are no longer in use so you don’t have to submit annual reports
- grant access to others in your organisation so they can also see, modify or withdraw notifications (depending on the role assigned to them by you in your client account)
- in-built support to help ensure you have correctly classified your medical device before submitting your notification.
These new functions enable you to keep your records up-to-date, support business continuity and provide us with better information about your devices in order to help TGA support you with the right information at the right time.
What if I have already submitted a notification(s) on the old databases?
If you have previously submitted a notification(s) on one of the old databases, you are not legally required to re-submit the same notification in the new database, but you should be mindful that we will be archiving the information previously submitted and it will no longer be used.
The TGA therefore strongly recommends you resubmit notifications into the new database, so that you can keep your information up-to-date, and the TGA can support you with updates and information that will impact you.
How do I access this new database and submit my notification?
Guidance for how to submit your notification is available. Please note, you will need to become a client of the TGA with access to the TBS online portal before you can access the database. There are instructions on the TGA website for becoming a client of the TGA.
If your organisation is already a client of the TGA, please contact the administrator of your organisation’s account and ask them to provide you with access to your organisation’s account.
How much does it cost?
There are no costs associated with becoming a client of the TGA, submitting or varying notifications using this form.
Can I submit annual reports for custom-made medical devices using this new database?
The new custom-made medical device database cannot be used to submit annual reports for custom-made medical devices. To submit an annual report, you will still need to:
Please note: You do not need to submit an annual report if your device meets the definition of a patient-matched medical device and has been registered for transition.
Does my custom-made medical device meet the new definition of a patient-matched medical device?
Custom-made medical devices are exempt from inclusion in the ARTG, but they are not exempt from regulation. Manufacturers and sponsors of custom-made medical devices still need to comply with TGA regulatory requirements including ensuring that the device meets the Essential Principles and reporting adverse events.
New definitions for medical devices that are personalised to suit an individual patient or health professional commenced on 25 February 2021. Under these changes the majority of devices that would previously have met the definition of a custom-made medical device will now meet the definition of a patient-matched medical device.
Custom-made medical devices that meet the new definition of patient-matched will no longer be exempt from inclusion in the ARTG. Transitional arrangements are in place to allow manufacturers and sponsors to continue supplying custom-made devices that meet the new patient-matched definition and are not included on the ARTG until 1 November 2024.
You can check if your custom-made medical device meets the new definition for a patient-matched medical device.
How do I notify the TGA and access the transition arrangements for my patient-matched medical device?
To notify the TGA, use the form for the new custom-made medical device database.
Once the form is submitted, you will have until the 1 November 2024 to submit an application for inclusion in the ARTG. More information about the inclusion process can be found on TGA's website.
Where can I get more information?
More information about the Personalised Medical Devices framework is available on TGA's website.
For general advice and information about the regulation of medical devices, please contact the Medical Devices Information Unit at devices@tga.gov.au.
If you have any questions or require any further assistance with the submission of your notification, please contact the TGA at PersonalisedDevices@health.gov.au