How to submit a custom-made medical device notification

4. Select New Custom-made Medical Device Notification

Pathway 2: Accessing the form from the TBS portal homepage

1. Log into your TGA Business Services (TBS) account
2. Click the ‘Applications’ dropdown menu on the homepage
3. Select ‘Medical Device Post Market Compliance’ from the menu.

4. You will be redirected to the PMR Compliance Dashboard. Select the Custom-made Medical Devices Notifications tile

5. Select New Custom-made Medical Device Notification

Step 3: Submitting your CMMD notification

All fields in the form are mandatory. You will need to complete all of them to submit successfully.

About the submitter

You can submit this form as either the manufacturer or sponsor.

If you submit the form as the Australian-based manufacturer, you will not have to submit the form a second time as the sponsor.

Our assumption is that Australian-based manufacturers are also sponsors.

Manufacturer

If you are the Australian-based manufacturer of the device, select the first option. Click ‘Australian manufacturer of a custom-made medical device’.

Your organisation name will be automatically displayed.

This will be the same organisation name you had used to apply for a client account to access the TBS Portal.

Sponsor

If you are the sponsor of the device, select ‘Australian sponsor of a custom-made medical device manufactured overseas’.

Your organisation name will be automatically displayed. This will be the same organisation name you had used to apply for a client account to access the TBS Portal.

Sponsor's own reference field

The ‘Sponsor’s own reference’ field is for your own reference. Use this field for tracking information. This could be a model or series number, a project name, or a record or file number.

Your ‘Sponsor’s own reference’ can be edited later, if needed.

Manufacturer details

If you are a sponsor, you will be asked to provide details of the manufacturer of your device.

This field will not display if you are completing the notification as a manufacturer.

Do not type the manufacturer’s name directly into the search field as it will not work.

You will need to click on the magnifying glass icon to select your manufacturer from a list. The magnifying glass icon is circled in red in the screenshot.

The manufacturer list will appear in a new look-up window. Search for the manufacturer by typing their name in the search field. Clicking the magnifying glass icon again circled in red.

Select your manufacturer by ticking the checkbox that corresponds to their name. Then click on the green ‘Select’ button at the bottom right of the pop-up window.

If the name of the manufacturer you are searching for is not on the list, a yellow error message will appear.

Manufacturer details not found in the look-up window list

If you can’t find the manufacturer in the look-up window, tick the checkbox to create a new manufacturer.

Check that the manufacturer does not already exist in the manufacturer list. Otherwise, a new manufacturer record will subsequently be added to the TGA Master manufacturer list.

After the ticking the checkbox, the ‘Manufacturer details’ fields will appear. Enter the appropriate details in each of the corresponding fields.

When entering the manufacturer’s address details, ensure you enter a physical address. It can not be a post office box or locked bag.

It acceptable, provide the manufacturer’s head office address instead of the address of the specific factory, lab or other location used to manufacture the device.

Under ‘Contact details’, enter the manufacturer’s email address and phone number.

Device details

Intended purpose and device description

Enter the intended purpose and device description in the dialog box. This is your own description of what the device is and what it is intended to do.

Global Medical Device Nomenclature (GMDN) Terms

GMDN Terms are an international naming convention used to identify and consistently describe medical devices.

In Australia, GMDN Terms are a key factor in determining a 'kind of medical device'. Devices are taken to be of the same “kind” if they have the same Sponsor, the same Manufacturer, the same Classification and the same GMDN term. For Class III medical devices, they must also have the same unique product identifier (UPI), such as the name or model number of the device.

For notification of a kind of device, you will need to select an appropriate GMDN term for your device. This is the name and 5-digit code specified by the GMDN agency.

Do not type the manufacturer’s name in the search field as it will not work.

Find the correct code, select the magnifying glass icon to launch the GMDN code list.

Type a description for your device’s intended purpose and search the code list.

Select the correct GMDN term and linked description from the list available.

If your GMDN term changes or is made obsolete after you have submitted your form, you will still be able to continue supplying the device.

If you use an obsolete GMDN term, you might not be able to submit further applications.

Device classification

The classification of your medical device will depend on several factors. These include how long the device is intended to be used for, and how invasive it is.

Check the classification of your medical device by using the online classification tool.

Use the drop-down menu to select the device classification.

You'll get a series of questions based on what classification level you select. They will prompt you to select yes or no.

If a selected response conflicts with a device's classification level, a warning appears in red.

Step 4: After you have submitted a notification

Once you have submitted your notification you will be sent to a page on your screen that will look like this:

From this page you can return to the dashboard, where you can view your submitted notifications. This is under ‘Submitted’.

Shown below:

Withdrawing a notification

Withdraw notifications no longer in use or that no longer contain the correct information by navigating to the ‘Submitted’ tab.

Locate the notification, click on the arrow on the far right. Select ‘Withdraw’:

Reactivate your withdrawn notification at any time: 

Withdrawn notifications will not be deleted. They will be archived for auditing purposes.

Modifying a notification

If you need to make any updates, locate your notification on the ‘Submitted’ tab.

Click the arrow on the far right and select ‘Edit’:

Once you click ‘Submit,’ your information will be resubmitted to the TGA.

When you click 'I agree' and submit, you are making a legal declaration. Any changes will be tracked for auditing purposes by the TGA.

More information

• Personalised medical devices
• Overview of refinements to regulation of personalised medical devices