Version 1.0, November 2016
It is important that information included in the ARTG is kept up-to-date and is correct from a public health, regulatory and transparency point of view. When any information included in the ARTG has changed, the sponsor should consider if they need to request the TGA to vary the respective ARTG entry.
There are many reasons why sponsors may require variation of their ARTG entries, for example the:
* The GMDN code must be current at the time when an application for ARTG inclusion of a kind of medical device is submitted to the TGA, and the code is expected to remain the same for the whole life of ARTG entry. TGA does not require the sponsor to amend the GMDN code if it becomes obsolete. However if the manufacturer decides to vary the GMDN code because it was made obsolete by the GMDN Agency, the sponsor may require the TGA to vary this information on the ARTG by submitting an application to the TGA.
** This guidance does not cover sponsor transfers and/or change of sponsor’s name. For requirements related to the sponsors transfers refer to Regulation 10F of the Therapeutic Goods Regulations 1990, and our guidance on Sponsor transfer and change of sponsor name amendments.
Decisions about variation of ARTG entries are made under Section 9D of the Therapeutic Goods Act 1989. We will always vary the ARTG entry if the sponsor requests a variation that:
We will not accept a request for variation if:
Version 1.0, November 2016
Schedule 9, Part 2 Item 2A(g) of the Therapeutic Goods Regulations 1990 sets out the fee to vary one ARTG entry. The fee is the same regardless of which variation application form you use, i.e.:
If you submit multiple Variation or DCR forms, you will receive an invoice with a fee for each form. Please remember that fees are non-refundable.
The TGA does not charge any evaluation fee for varying ARTG entries, even when assessment of the information (e.g. clinical evidence) is required for the TGA to be satisfied that the requested variation does not indicate any reduction in the quality, safety or performance of the medical device.
The variation request forms are within the TGA Business Services (TBS) online portal, and there are three application forms available:
Guidance on selecting and completing these forms is available from page 8: How do I request a variation of my ARTG entry?
These forms are designed to request variation of the information included in the ARTG for specific characteristics related to the device of the kind (UPI, number of devices, functional description, and variant list).
We generally ask sponsors to provide information that demonstrates that the variation does not indicate any reduction in the quality, safety or performance of the medical device.
In cases where the design of the device has changed, sponsors are asked to demonstrate that this variation neither indicates any significant change of the intended purpose of the devices of the kind, nor results in the device no longer being the device of the same kind. You can attach additional information with this application to explain the required change if you wish (maximum 1 page).
A Device Change Request (DCR) is the most frequently used form. It is a very simple form where the sponsor can briefly describe the required variation in a free text field.
When a DCR is received, the TGA will send you a letter requesting that you describe in detail the required change (section 41JA Notice). You may also be asked to provide other information as specified to support the requested variation.
Generally, sponsors should submit one DCR per ARTG entry.
Sometimes we may decide to vary some ARTG entries on our own initiative (could be based on a request to vary one ARTG entry). In these cases, sponsors are not required to submit multiple DCRs.
Examples of this could be a change of the:
To check your eligibility, work through the questions below. If you answer 'YES' to all of the questions in either Group A or Group B, you may be eligible to submit one DCR to make the same change to a number of ARTG entries:
Go to Requesting the same change to multiple ARTG entries for the process to follow.
When considering requests for variation of the manufacturer's address and/or name, we will assess whether the person responsible for the design, production, packaging, and labelling of the device is still the same.
If the manufacturing quality system and control over the design and production have changed, we will not accept the DCR and will require the sponsor to submit a new application for inclusion of the kind of device in the ARTG.
Any change(s) proposed by the manufacturer must be assessed and approved by the body that issued the conformity assessment certification in relation to the kind of device (either TGA conformity assessment certificate or EC Certificate issued by a European NB).
If the change(s) is approved, a revised certificate may or may not be issued, depending on whether the information appearing on the certificate requires updating.
This process must be completed prior to seeking a variation of your ARTG entry.
Answer the following questions to decide which application form you need to use:
In ALL other cases, use the Request Change (Device Change Request) form.
You need to login into your TGA Business Services (TBS) account to access the application forms. If you don't have an account/access, follow the instructions at TGA Business services: getting started with the TGA.
Enter your user name and password.
From the Applications menu, under the Medical Device list, select the relevant variation type. Indications for the use of each form are detailed above in 'Types of Variation Applications'.
The form requirements for each variation type are different, and we have outlined these in three sections:
Once the sponsor has paid the invoice, the application joins the queue for the assessment.
The application is reviewed by an assessor who makes a recommendation to the Delegate.
The TGA may request further information under section 41JA of the Act to make an informed decision on whether the requested change is acceptable and does not change the kind of device in the Register.
The TGA Delegate makes a decision under section 9D of the Act to:
The Sponsor Details will be pre-populated with your information, but correct these if necessary. There is a field under the Application Details for a Sponsor's own reference, but this will be populated later in the process.
You need to search for the ARTG entry you wish to vary, and selecting the Search button on page 1 of the form will open a new search window titled Code Picker - ARTG ID.
This will list all of the ARTG entries you have for Class III and AIMD medical devices. If the list is long (e.g. multiple pages), you can search by key words in the Search for… field to narrow the list.
To choose the entry you want to vary, select it directly from the list. Once selected, the Code Picker window will close.
Once you have chosen the correct entry, its ARTG number will appear on page 1 of the form. To continue, select the Clone button on the form which will copy all the details from the selected ARTG entry for use in the new application to vary.
Page 1 of the application form will then show the ARTG entry to be varied within the Sponsor's own reference field.
Select Next to continue.
You'll then go to the next page of the form, where you'll make the variation(s) to the ARTG entry. All the details you see initially are the same as the original device you selected to change.
You can modify the details for the Unique Product Identifier, the Functional description, and the Total number of devices covered.
To add an entry to the Variant List, first select the relevant Variant type (in this example, mL) from the drop-down list.
Then include the new amount for the Variant range, and select Add. The Variant List will then be updated. You can only add one entry at a time.
A value in the variant range must only relate to one physical characteristic of the device, e.g. diameter.
Different sizes of a variant type can be listed individually in the variant list or, for example, listed once with a variant range of "4 to 9", as long as that range doesn't also cover other physical characteristics of the device.
To remove an entry from the Variant List, select the entry number (#) you want to delete using the small dropdown menu located directly below the list. Then select the Delete button. You can only delete one entry at a time.
Once you've finished modifying on this page, select the Next button to proceed.
The final page of the form allows you to review information, and attach supporting information.
To add an attachment, select the Add button which opens the File Upload box.
You will need to select the Document type (in this case, a Design Examination Certificate), and then select the Browse button to search for the document. Once complete, select the Add button to attach the document to your application.
Please agree with the terms of the declaration, and select the Validate button.
If there are any validation errors, they will appear in 'blue bold' text in the top left hand corner of the form. You need to correct any of these to proceed.
Once you have successfully validated the application, select the Continue button to submit it.
The fee for this change does not appear on the application form. We will email a tax invoice to you, or you can access one by selecting the Invoice button on the confirmation screen.
To do this, select the View Entire App button.
If you want to go back and change anything (or if you are happy to submit the application), select the Edit button to continue.
If you select Close, the application will be saved in your Drafts list.
The fee for this change does not appear on the application form; however a tax invoice is emailed to the sponsor.
An application to vary an IVD entry is similar to the Class III/AIMD process, however the first page displays as Variation of IVD Device Application.
You need to search for the ARTG entry you wish to vary, and selecting the Search button on page 1 of the form will open a new search window titled Code Picker - ARTG ID.
This will list all of the ARTG entries you have for IVD medical devices. If the list is long (e.g. multiple pages), you can search by key words in the Search for… field to narrow the list.
To choose the entry you want to vary, select it directly from the list. Once selected, the Code Picker window will close.
Once you have chosen the correct entry, its ARTG number will appear on page 1 of the form. To continue, select the Clone button on the form which will copy all the details from the selected ARTG entry for use in the new application to vary.
Page 1 of the application form will then show the ARTG entry to be varied within the Sponsor's own reference field.
Additional questions will also appear under the Application Class Details heading, and these need to be completed before you can continue.
Selecting Yes to the first question opens additional fields to complete.
Please be aware that pressing the red cross immediately next to any entries in the Active IVD Names and Categories list will render that entry inactive, and remove it from the ARTG certificate.
Complete the relevant fields, and select the Add button to include the additional IVD on the New IVD Names and Categories list. Once you have added the extra details, select the Next button to continue.
The final page of the form allows you to review information, and attach supporting information.
To attach supporting information, select the Add button which opens the File Upload box.
You will need to select Document type, and then select the Browse button to search for the document. Once complete, select the Add button to attach the document to your application.
Please agree with the terms of the declaration, and select the Validate button.
If there are any validation errors, they will appear in 'blue bold' text in the top left hand corner of the form. You need to correct any of these to proceed.
Once you have successfully validated the application, select the Submit button.
The fee for this change does not appear on the application form. We will email a tax invoice to you, or you can access it by selecting the Invoice button on the confirmation screen.
There is only one page for this form. Confirm the Sponsor details before proceeding.
Enter the ARTG number you wish to change, select from the Change type options, and then provide a description of the requested change.
Once finished, select Validate. If there are no validation errors, select Submit.