The new article further describes in detail the specific approach to be followed when making a submission, highlighting the key points to be considered by the parties involved.
Table of content
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.
Submitting a CMMD Notification
According to the guidance, the process of submitting a notification for a Custom-Made Medical Device (CMMD) requires all fields in the form to be completed. The notification can be submitted by either the manufacturer or the sponsor. Every mandatory field must be filled out to ensure a successful submission.
About the Submitter
The form allows submission by either the manufacturer or the sponsor of the device. If an Australian-based manufacturer submits the form, there is no need for a separate submission by the sponsor.
This is because the assumption is made that Australian manufacturers are also the sponsors of their devices. If the manufacturer is Australian-based, the option “Australian manufacturer of a custom-made medical device” should be selected by clicking on the corresponding radio button.
The name of the manufacturer’s organization (or the submitter’s own name) will automatically appear based on the information used when creating the client account for access to the TGA Business Services (TBS) Portal. If the submitter is acting as the sponsor of a custom-made medical device manufactured overseas, the option “Australian sponsor of a custom-made medical device manufactured overseas” should be selected.
Again, the name of the sponsor’s organization will automatically appear, using the same information provided during the account creation process.
Sponsor’s Own Reference Field
The “Sponsor’s own reference” field is included for sponsors to track and manage information about the specific device being submitted.
This field can contain details like a model or series number, a project name, or any other relevant record or file number. The reference entered in this field can be modified later, if necessary.
Manufacturer Details
If the notification is being completed by a sponsor, details about the manufacturer of the device will need to be provided. This step is not necessary for manufacturers completing the form on their own behalf.
Sponsors are required to select the manufacturer from a pre-existing list by clicking on the magnifying glass icon, which is highlighted in red in the provided screenshot. Once the magnifying glass is clicked, a list of manufacturers will appear in a pop-up window.
The sponsor can search for the correct manufacturer by entering the manufacturer’s name in the search field and clicking on the magnifying glass again. After locating the correct manufacturer, the sponsor should check the corresponding box and click the “Select” button at the bottom right of the window.
Manufacturer Details Not Found in the Look-Up List
If the manufacturer’s name does not appear in the look-up list, the sponsor can create a new entry by ticking the checkbox to add a new manufacturer. It is important to ensure the manufacturer does not already exist in the list to avoid duplicate records.
If a new entry is created, it will be added to the TGA Master manufacturer list. Once the checkbox is selected, fields will appear to input the necessary details for the manufacturer, including a physical address.
Post office boxes or locked bags are not acceptable, but the manufacturer’s head office address can be used instead of the specific production site. Contact details, including the manufacturer’s email address and phone number, will also need to be provided.
Device Details
The device details section requires information about the intended purpose and description of the device.
Manufacturers or sponsors should enter their own description of what the device is and its intended use. This section helps provide clarity about the nature of the device and its application.
Global Medical Device Nomenclature (GMDN) Terms
The Global Medical Device Nomenclature (GMDN) system is an internationally recognized naming convention for medical devices used in Australia to help determine a “kind” of device. An appropriate GMDN term and code must be selected for the device being submitted.
This is done by launching the GMDN code list using the magnifying glass icon, searching for a term that matches the intended purpose of the device, and selecting the correct code and description from the available options. If the GMDN code for a device is updated or becomes obsolete after submission, the device can still be supplied under the existing notification.
However, future applications may not be submitted using the obsolete GMDN code.
Device Classification
The classification of a medical device is determined based on several factors, including how long the device is intended to be used and the level of invasiveness. The classification rules are outlined in Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002, and manufacturers or sponsors can check the classification using an online tool provided by the TGA.
After selecting the appropriate classification from the drop-down menu, the user will be prompted to answer a series of yes/no questions related to the device. If the responses conflict with the selected classification level, a red warning text will appear, indicating the inconsistency.
The correct classification of the device is crucial to ensure compliance with regulatory standards and to avoid errors in the notification process.
Conclusion
In summary, the submission process for a Custom-Made Medical Device notification involves providing comprehensive information about the submitter (whether manufacturer or sponsor), the manufacturer’s details (if applicable), and specific details about the device. Accurate classification and adherence to GMDN terms are essential to ensure a smooth submission process. By following the outlined steps, manufacturers and sponsors can comply with TGA regulations and effectively submit their CMMD notifications.
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