Varying your medical device or IVD ARTG entry

Background

This guidance is for sponsors applying for a variation to the Australian Register of Therapeutic Goods (ARTG) entry of a medical device or IVD medical device. 

It is important that the 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 us to vary the respective ARTG entry.

If you want to correct an ARTG entry that is incomplete or incorrect, you will need to apply to us under subsection 9D (1) of the Therapeutic Goods Act 1989 by submitting either a Variation to Class III/AIMD, IVD Variation or Device Change Request (DCR) application. 

Changes that may require variation of an ARTG entry:

• Information entered on the ARTG is not complete or correct
• Manufacturer’s details (e.g. name or address) have changed
• Change of GMDN code by the manufacturer to a more relevant, active, or preferred code
• Change to the intended purpose of the device by the manufacturer (e.g. broadening or reducing clinical indications)
• Manufacturer has added or removed product variants
• Total number of devices has changed (increased or decreased)
• Manufacturer changed the Unique Product Identifier (UPI)
• Sponsor wants to vary the list of IVD devices included in the ARTG entry

There is no legislated timeframe for the evaluation of an application to vary an ARTG.

Note
This guidance does not cover notification of a change in sponsorship or change of sponsor name. 

For these changes, you are required to complete the relevant form related to the changes and make the relevant declarations which are processed under regulation 10F of the Therapeutic Goods Regulations 1990. 

Change of Sponsor forms are available on our website.

Decision to vary an entry

Decisions about variations of ARTG entries are made under Section 9D of the Therapeutic Goods Act 1989. 

We will vary the ARTG entry if the sponsor requests a variation that:

• reduces the class of persons for whom the kind of medical device is suitable, or
• adds a warning, restriction or precaution.

We will not accept a request for variation if:

• the result of the proposed variation would be that the device is no longer a device of the same kind, or
• the proposed variation indicates any reduction in the quality, safety or performance of the medical device for the purposes for which it is to be used.

An application to vary an ARTG must not change the kind of device and must meet the criteria of 41BE of the Therapeutic Goods Act 1989.
1. 41BE - Therapeutic Goods Act
2. 41BE of the Therapeutic Goods Act (the Act) states that a device is the taken to be of the same kind as another medical device if they:
(a) have the same sponsor; and
(b) have the same manufacturer; and
(c) have the same device nomenclature system code; and
(d) have the same medical device classification; and
(e) are the same in relation to such other characteristics as the regulations prescribe, either generally or in relation to the medical devices of the kind in question.

Unique Product Identifier (UPI)

For Class III, Class AIMD, and Class 4 IVD medical devices (excluding immunohaematology reagents that are Class 4 IVDs), and IVD companion diagnostics, the unique product identifier (UPI) also defines the kind of medical device. 

Regulation 1.6 of the Therapeutic Goods (Medical Device) Regulations 2002 specify this in relation to s 41BE(1)(e) of the Act. 

Variant

The Regulations dictionary defines a ‘variant’ as a medical device, the design of which has been varied, to accommodate different patient anatomical requirements (for example, relating to the shape, size, length, diameter, or gauge of the device) or any other variation approved by the Secretary for this definition, if the variation does not change the intended purpose of the device. 

If you are unsure whether you need to make an application to vary your ARTG, contact the Devices Information Team.

Fees

The current fees for variations to an ARTG inclusion can be found in our Schedule of fees and charges under ‘Variations’. These are set in accordance with Schedule 9, Part 2 Item 2A of the Therapeutic Goods Regulations 1990.

The application fee for a Variation is different depending on the class of the medical device.

The fee paid for the application is not refundable.

The variation fee for relinking manufacturer evidence from an EU MDD certificate to an EU MDR certificate is reduced. An application can include up to 10 ARTG entries under the one fee, if all of them are relinking to the same manufacturer evidence ID.

Forms

The variation application forms are located within the sponsor TGA Business Services (TBS) online portal.

There are three application forms available:

1. Class III/AIMD variation application form

2. Request change application form (Device Change Request)

3. IVD Variation application form 

Class III/AIMD variation application form

A variation form is designed to request variation of the information included in the ARTG for a specific device of the kind of which is either Class III or Class AIMD.

A variation can be submitted to vary the UPI, total number of devices, functional description or product variant list.

Note that an ARTG entry is not limited to the information visible in the public ARTG entry. It also includes any supporting information provided with the dossier or subsequent variations that are held by us and were considered to be relevant to the initial decision.

The following information should be attached to the variation application to substantiate any changes and that demonstrate that the variation does not reduce the quality, safety or performance of the medical device:

• Sponsor explanation of changes
• Design Examination certificate or equivalent document, if applicable
• Manufacturer’s Declaration of Conformity (DoC), if applicable
• Instructions for Use (IFU), if applicable
• Information provided with the device (labelling), if applicable
• Surgical technique, if applicable
• Approval of significant change document from the notified body, if applicable

In cases where the design of the device has changed, the manufacturer is requested to demonstrate that the 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. 

All changes must be approved by the relevant notified body issuing the certification for that specific kind of device. This process must be completed before seeking a variation of your ARTG entry.

Class III – Software for programming another medical device

For Class III software that is used for the programming of another medical device and the software has been versioned to incorporate a new medical device (Class III or Class AIMD), the new (hardware) device must first be approved by us before the submission of a variation application. 

We will process these variations within a target timeframe of 3-5 business days to allow for the transition of the software device to be used with the (hardware) devices for which it is intended.

Device Change Request (Request Change) Application Form 

A Device Change Request (DCR) is the most frequently used form to vary information in the ARTG entry for medical devices and IVD medical devices 

A Device Change Request can be submitted to vary manufacturer details, GMDN code and term, intended purpose, and de-linking and re-linking manufacturer evidence ID.

The following information can be attached to the Device Change Request application to substantiate any changes and do not reduce the quality, safety or performance of the medical device or IVD medical device:

• Additional supporting documentation (e.g. manufacturer or notified body letter)
• Design Examination certificate or equivalent document, if applicable
• Manufacturer’s Declaration of Conformity (DoC), if applicable
• Instructions for Use (IFU), if applicable
• Information provided with the device (labelling), if applicable
• Surgical technique, if applicable
• Approval of significant change document from the notified body, if applicable

Note
The sponsor of an ARTG entry (or agent on behalf of the sponsor) is the only person who can request to vary that entry. 

A DCR application from someone who is not the sponsor of the ARTG entry will not be processed.

Multiple ARTG entries – Same change

The sponsor can submit one DCR form for up to 10 ARTG entries where the request is the same for each entry.

Request for information

We may ask you for more information under section 41JA or section 31 of the Therapeutic Goods Act 1989 to enable the delegate to make an informed decision on whether the requested change is acceptable and does not change the kind of device in the Register.

It is an offence not to comply with such a notice or to provide information that is false or misleading in a material particular.

We allow you to provide the information or documents with a reasonable time, being not less than 10 working days from the day on which the notice is given, as is specified in the section 41JA or section 31 notice. The response period will be clearly stipulated in the notice. If we have not given you sufficient time to respond, you may ask us for an extension in writing to the delegate requesting an extension of time.

Manufacturer – Same Quality Management System (QMS)

When considering requests for variation of the manufacturer's name or address, we will assess whether the manufacturer responsible for applying the QMS related to 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 has changed, (acquisition, bankruptcy, death, winding up) we may not accept the request to change the ARTG entry and may require the sponsor to submit a new application for inclusion of the kind of device in the ARTG.

If the manufacturer can demonstrate that the QMS remains exactly the same and has not changed due to a name change or relocation, then this will be accepted.

Intended purpose – changes

If the manufacturer has changed the intended purpose of the device of which has not been previously assessed by us, such as broadening the clinical indications, the sponsor is required to apply for a change to the ARTG.

Changes that expand or contract the intended purpose must not change the kind of device or the classification of the device. This is required to be taken into consideration before submitting the variation application.

GMDN code and term

The GMDN code and term applied to the kind of device in the ARTG at the time of inclusion is valid for the whole life cycle of the ARTG entry.

We do not require the sponsor to vary the GMDN code if it becomes obsolete (inactive) in the TGA GMDN or the GMDN agency database.

However, the manufacturer who is responsible for determining the appropriate GMDN code for a device or range of devices may decide to apply a more relevant active term to describe their device. In this case the sponsor can request to vary the GMDN code on the ARTG entry by submitting an application to us.

The GMDN code and term must not change the kind of device in the ARTG and must align with the intended purpose, classification, and product characteristics of the device. 

TGA Conformity Assessment Certificates

For ARTG entries supported by TGA Conformity Assessment Certificates, the manufacturer must, under section 41EJ of the Act, notify our Devices Conformity Assessment Section (DCAS) of any plans for changes to the quality management system; product range covered by those systems; or product design of the kinds of medical devices covered by the TGA issued conformity assessment certificate.

The sponsor should first contact devices@tga.gov.au to check whether they are required to submit a Conformity Assessment Application Form for any changes to the device and subsequent change to the ARTG entry.

IVD Variation application form

Class 1, 2 and 3 IVD medical device ARTG entries are for a kind of device. The supply of an additional device of the kind requires notifying us if the additional device is consistent with a device described by Regulation 5.12 of the Regulations.

The variation of the ARTG entry for the approval to supply the additional device of the kind requires the identification of the additional device. The application form has Device Product Characteristic questions that are mapped to Regulation 5.3(1)(j) of the Regulations. If you answer yes to any of the questions in the Device Product Characteristics section of the form you will be prompted to identify the device (with the name of the device, as it appears on the labelling for the device). You must use the ‘Add’ function to add the additional device of the kind to the application for variation. Do not delete the existing active IVD unless you are no longer supplying the device.

Some devices require notification but are not captured by the questions in the Device Product Characteristics section of the form. For example, devices that are captured by Regulation 5.3(1)(j)(viii) are not required to be identified, unless the device is also consistent with another sub-paragraph of Regulation 5.3(1)(j).

Note 
A variation is needed to add another device of the kind. If the variation is about information in the ARTG entry or about a performance characteristic for existing devices, a change request application is needed. 

A change to the intended purpose in the ARTG entry also requires a change request application. However, if you intend to supply an additional device of the kind that requires notification to us, and a change in the intended purpose in the ARTG entry is also required, you should attach a document including the replacement intended purpose to the variation application form.

When applying for a variation to an IVD medical device attach the manufacturer’s Australian declaration of conformity.

Note
The IVD variation form is not applicable for Class 4 IVDs as these ARTG entries have a single UPI.

Making a decision on your application

Approval

Once we have made a decision to vary the ARTG, we will send you a decision letter. Read the decision letter carefully, especially the list of changes approved that is in line with the variation request. You are required to wait for approval before implementing a change. You are breaching a condition of inclusion in the ARTG if you implement a variation before the Secretary has approved it.

Rejection

If the delegate makes a decision not to vary the ARTG, the decision letter will include a statement of the reasons for the decision; and information on your rights to seek a review of the decision.

Under section 60 of the Therapeutic Goods Act, a person whose interests are affected by an initial decision made under the Act may, by notice in writing given to the Minister, request the Minister to reconsider the initial decision.

Which form to use

The following questions will assist you when deciding which application form you need to use:

4. Is your device a Class III or AIMD device, and are you requesting to vary information relating to any of the following:

   • UPI
   • Total number of devices
   • Functional description
   • Product variant list

• YES - use the Class III/AIMD Variation Application form.

5. Is your device an IVD device, and is the additional device of the kind a device that requires notification (Regulation 5.12)?

• YES - use the IVD Variation Application form.

In ALL other cases, use the (Device Change Request) form.