About GMDN Terms
Note
The information provided in this document is relevant to medical devices and Class 4 in vitro diagnostic (IVD) devices, however there are some differences for Class 1, 2 and 3 IVDs that sponsors and manufacturers of these devices should be aware of. More information is available on the TGA website.
Global Medical Device Nomenclature (GMDN) Terms are an international naming and grouping 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 following characteristics:
- the same Sponsor;
- the same Manufacturer;
- the same classification;
- the same GMDN Term; and
- for Class III medical devices, Class AIMD medical devices and Class 4 IVD devices (other than an immunohaematology reagent that is a Class 4 IVD medical device), the same unique product identifier (UPI).
The concept of a kind of medical device forms the basis of such things as:
- conformity assessment;
- applications for inclusion in the Australian Register of Therapeutic Goods (ARTG);
- custom-made medical device notifications;
- registrations for transition; and
- adverse event notifications.
GMDN Terms are made up of a five (5)-digit numeric Code, a Term Name and a Definition.
GMDN Code: 47569
GMDN Term Name: Scalpel, single-use
GMDN Definition: A sterile, hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device.
Why we use GMDN Terms
GMDN Terms are used as a consistent way for manufacturers, sponsors, suppliers and regulators around the world to communicate with each other about medical devices. From a regulatory perspective, the use of GMDN Terms helps to streamline processes around approval and monitoring of medical devices, and facilitates information sharing between agencies when safety or performance concerns arise. For manufacturers, sponsors and suppliers, it provides a straightforward way of categorising products.
Where to find GMDN Terms
You can access the full list of GMDN Terms by registering for an account on the GMDN Agency website. The GMDN Agency is a not-for-profit organisation responsible for creating and maintaining GMDN Terms. The GMDN Agency offers a basic plan that is free for all users. More information is available on the GMDN Agency's registration page.
Choosing the right GMDN Term
It is the manufacturer's responsibility to choose the most appropriate GMDN Term for any medical device they manufacture. Sometimes there are multiple GMDN Terms that could apply to a kind of device. If you are the manufacturer of a device, you should carefully consider all available GMDN Terms to ensure you choose the most appropriate GMDN Term for your device based on what type of device it is, and how it is intended to be used. Ensure you document your rationale for selecting the GMDN Term.
Note
The TGA may reject an application for inclusion in the ARTG if the GMDN Term used in the application is unsuitable, including if it is an obsolete GMDN Term. If an application is rejected due to a mistake made by the Sponsor, the application fee is not refundable.
Choosing the right GMDN Term
Upkar plans to produce dentures and overdentures for both the upper and lower jaw using four different materials: a polymer, a ceramic and chrome cobalt. These materials are used in different combinations depending on the patient's needs.
Upkar searches the GMDN Agency database using the search term 'denture'. He notes the following:
- 'Complete lower denture' and 'Complete upper denture' are separate GMDN Terms, but 'Partial denture' and 'Overdenture' are single GMDN Terms specifically stated to cover both upper and lower jaw products; and
- The definitions associated with all four of these GMDN Terms specifically state that the devices can be made from a variety of different materials.
Therefore, although Upkar will produce dentures and overdentures using several different combinations of materials, they will all be described by four (4) GMDN Terms.
Frequently asked questions
I sourced a GMDN Term from the GMDN Agency's list, but now that I'm trying to submit my application in TGA Business Services (TBS) I can't find it. What should I do?
Sometimes TBS does not contain GMDN Terms been recently made available through the GMDN Agency. If you have used a GMDN Term sourced from the GMDN Agency that is not available in TBS, please send an email to devices@health.gov.au asking for it to be added.
There is no GMDN Term that describes my device. What should I do?
If you cannot find a suitable GMDN Term to match the characteristics and intended purpose of your device, you should contact the GMDN Agency and request assistance. In some cases, a new GMDN Term may need to be developed.
I sourced a GMDN Term from the GMDN Agency, but the Term Name or Description is different from that in TBS. What should I do?
TBS does not always align perfectly with the GMDN Agency list. In many cases even though the wording in the GMDN Term Name and Definition are different between the two, they have the same meaning or intent. Work is underway to better align the two lists, but in the meantime, if you have sourced your GMDN Term from the GMDN Agency and it is significantly different from what is in TBS you should:
- use the applicable GMDN Term from the GMDN Agency list; and
- send an email to devices@health.gov.au advising of the issue.
The GMDN Term in TBS is applicable to my device, but the same GMDN Term in the GMDN Agency's list describes a different device. What do I do?
The GMDN Agency is responsible for maintaining GMDN Terms, so you should select the appropriate GMDN Term from the GMDN Agency list as these GMDN Terms are correct and current. Work is underway to better align the two lists but, in the meantime, if you find a GMDN Term that is significantly different between the two databases you should:
- use the applicable GMDN Term from the GMDN Agency database; and
- send an email to devices@health.gov.au advising of the issue.
The GMDN Term in TBS is applicable to my device, but the GMDN Agency has made that Term obsolete. No other Terms in the GMDN Agency's list appropriately describe my device. What should I do?
If a GMDN Term has been made obsolete by the GMDN Agency, it cannot be used for any new applications to the TGA. If you come across an obsolete GMDN Term in TBS, you should:
- not proceed with submitting an application using the obsolete GMDN Term, as doing so may result in you losing your application fee; and
- send an email to devices@health.gov.au advising of the issue.
If you cannot find a suitable active GMDN Term to match the characteristics and intended purpose of your device, you should contact the GMDN Agency and request assistance. In some cases, a new GMDN Term may need to be developed.
I am the sponsor of a current ARTG entry, but the GMDN Term that I used when I submitted my application to the TGA has now been made obsolete by the GMDN Agency. Do I need to do anything?
No, once a GMDN Term has been applied to a product, the GMDN Term can continue to be used throughout the life of that unchanged product.
You may, however, submit a change request application to change the GMDN Term applied to an ARTG entry if you wish, provided the proposed GMDN Term does not change the 'kind' of device that the ARTG entry relates to. For example:
Current GMDN Term: Scissors general (INACTIVE CODE)
Intended purpose as stated in the ARTG entry: Scissors used in orthopaedic surgery to dissect tissue.
Proposed GMDN Term: Scissors, orthopaedic (ACTIVE CODE)
If in the future you submit further applications for inclusion in the ARTG, you will not, however, be able to use this or any other obsolete GMDN Term.
TBS has a GMDN Term that best describes my device but it's not in the GMDN Agency's list. Can I ask the GMDN Agency to reinstate it?
No, once a GMDN Term has been made obsolete by the GMDN Agency it will not be reinstated and it cannot be used for any new applications to the TGA. If you cannot find a suitable GMDN Term in the GMDN Agency list matching the characteristics and intended purpose of your device, you should contact the GMDN Agency and request assistance. In some cases, a new GMDN Term may need to be developed.
Please note: if an application is rejected due to the Sponsor using an obsolete GMDN Term, the application fee is not refundable.
A particular GMDN Term has been made obsolete by the GMDN Agency, but there are multiple entries in the ARTG using the same GMDN Term. Why can't I use this GMDN Term?
Once a GMDN Term has been applied to a product, the code can continue to be used throughout the life of that unchanged product. If a GMDN Term has been made obsolete by the GMDN Agency, it cannot be used for any new applications to the TGA.
I can't find a GMDN Term for a patient-matched version of my device.
Patient-matched medical devices are not regulated any differently to mass-produced medical devices, and so do not need 'special' GMDN Terms. The GMDN Term chosen by the manufacturer should be the GMDN Term that best describes the device, regardless of whether it is patient-matched or not. If you cannot find a suitable GMDN Term to match the characteristics and intended purpose of your device, you should contact the GMDN Agency and request assistance. In some cases, a new GMDN Term may need to be developed.
Note
Work is currently underway to better align the TGA database with the GMDN Agency database. Any discrepancies between the two should be reported to devices@health.gov.au.
Version history
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V1.0
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Original publication
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Devices Emerging Technology & Diagnostics Section
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October 2021
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