The article highlights the key points associated with notifications for certain types of medical devices in the context of their specific regulatory nature.
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The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to notifications in the content of patient-matched and custom-made medical devices. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
In particular, the document describes in detail the approach to be followed when making a submission via the respective online system and also provides additional explanations. This guide has been developed to support manufacturers, sponsors, and suppliers in submitting notifications for two specific types of medical devices: Custom-Made Medical Devices (CMMD) and Patient-Matched Medical Devices (PMMD).
The notification process for both device types can be completed using a singular CMMD notification form. Each form submission takes approximately ten minutes per device “kind”, whether it is being manufactured or supplied.
According to the document, a new database system has been introduced, replacing the previous two systems used to notify the TGA of CMMD and PMMD. While any notifications made in the old databases remain valid, these notifications are not cross-linked to the new database.
As a result, all notifications made using the old system before August 2022 have been archived, and notifications via the old databases ceased at that time. For those who have already submitted CMMD or PMMD notifications through platforms such as Citizen Space, it is strongly advised to resubmit their notifications using the new database.
The TGA will no longer rely on the information stored in the previous systems to maintain contact with registrants. By resubmitting, organizations will be able to view, modify, and withdraw their notifications.
Additionally, this will enable the TGA to more effectively provide updates and support relevant to manufacturers’ or suppliers’ products.
Who Needs to Submit a CMMD Notification
Under current regulations, manufacturers and sponsors involved in the production, supply, or import of CMMDs are required to notify the TGA within two months of the device’s manufacture or first supply. This notification requirement applies to any “kind” of device that falls under the CMMD category.
Who Needs to Submit a PMMD Notification
In contrast to CMMDs, Patient-Matched Medical Devices (PMMDs) have a specific transition notification requirement. Manufacturers and sponsors who are currently making or supplying PMMDs and intend to continue doing so after 1 July 2029 must submit a transition notification by 1 November 2024.
This transition period provides a deadline for PMMDs to be included in the Australian Register of Therapeutic Goods (ARTG) after 1 July 2029. It is important to note that under the Therapeutic Goods (Medical Devices) Regulations 2002, PMMDs will remain exempt from ARTG inclusion until 1 July 2029.
During this time, manufacturers and suppliers can continue to make or distribute these devices without the need for ARTG inclusion. However, once the exemption period ends, all PMMDs – including those previously notified – must be included in the ARTG to be legally imported into, supplied within, or exported from Australia unless they meet exemption criteria or are otherwise approved by the TGA.
Exemptions for PMMDs
Devices that are supplied in small quantities – specifically five units or less per financial year – are exempt from ARTG inclusion requirements. While these exempt devices do not need to be listed in the ARTG, they are still subject to regulatory oversight.
Manufacturers and sponsors of exempt devices must comply with all relevant TGA regulations, including adherence to the Essential Principles for medical devices and applicable advertising standards. Further details on the extended transition period and exemption conditions for PMMDs are provided under the “Transition Plan” section of this guide.
Step 1: Getting Started with the TGA
Before submitting a CMMD or PMMD notification, manufacturers and sponsors must obtain a client identification number (Client ID) and apply for access to the TGA’s secure online services via the TGA Business Services (TBS) portal. The TGA website offers a range of resources designed to help clients navigate this process and utilize the TBS portal effectively.
Once access is granted, clients will be able to submit notifications for both CMMD and PMMD devices.
Step 2: Access to the Notification Form
After successfully registering as a TGA client and gaining access to TBS, manufacturers and sponsors can access the notification form through two different pathways. The choice of pathway depends on user preference, but both options provide direct access to the required forms.
Pathway 1: Accessing the Form Directly
To access the notification form directly:
- Log in to the account through the TGA PMR Compliance Dashboard;
- From the PMR Compliance Dashboard, select the “Custom-Made Medical Devices Notifications” tile;
- Choose the option for “New Custom-Made Medical Device Notification” from the Custom-Made Medical Devices Notifications Dashboard.
Pathway 2: Accessing the Form via the TBS Portal Homepage
Alternatively, users can log in through the TGA Business Services (TBS) Portal Homepage:
- Log into the account;
- On the homepage, click on the “Applications” dropdown menu and select “Medical Device Post Market Compliance”;
- The user will then be redirected to the PMR Compliance Dashboard, where a user should select the “Custom-Made Medical Devices Notifications” tile.
- From there, select “New Custom-Made Medical Device Notification” on the Custom-Made Medical Devices Notifications Dashboard.
Both pathways ensure streamlined access to the notification forms and support the accurate and timely submission of information regarding custom-made and patient-matched medical devices.
Conclusion
In summary, submitting notifications for Custom-Made Medical Devices and Patient-Matched Medical Devices is a crucial regulatory step for manufacturers, sponsors, and suppliers in the Australian market. The transition to the new TGA database, while requiring the resubmission of previous notifications, ensures that up-to-date information is accessible and modifiable by organizations. For further support, the TGA provides resources through its website, helping users navigate both CMMD and PMMD notification processes efficiently.
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