Using Global Medical Device Nomenclature (GMDN) terms for medical devices

See: 

• section 41BE(3) of the Therapeutic Goods Act 1989
• the Therapeutic Goods (Medical Devices) Regulations 2002
  • Regulation 1.7 (Device nomenclature system codes).

GMDN example

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.

IVD example

Note

Class 1, 2 and 3 IVDs are collective Terms, referred to as 'categories' by the GMDN Agency - external site, that represent a group of similar IVDs. These are identified by a code (which starts with 'CT' followed by 3 or 4 numbers), a name and a definition.

CT Code: CT826

GMDN CT Name: Constitutional chromosomal disorder IVDs

CT Definition: IVDs that are intended to be used in genetic testing for diagnosing, monitoring or predicting the presence of chromosomal abnormalities of a constitutional nature (i.e.. present in all cells of the body).

More information on GMDN terms for IVDs is available at The use of GMDN codes for IVD medical devices in Australia.

GMDN terms help:

• manufacturers categorise their products
• manufacturers, healthcare providers, regulators and consumers communicate consistently worldwide
• organisations streamline medical device approval and monitoring processes
• organisations share information when safety, performance or performance quality concerns arise.

Where to find GMDN terms

GMDN terms are provided by the GMDN Agency website - external site.

You can access the full list of GMDN terms by registering for an account.

The GMDN Agency is a not-for-profit organisation responsible for creating and maintaining GMDN Terms.

You may need to register with the GMDN Agency if there isn't a suitable GMDN term or you need a new GMDN term to describe your device.

More information is available on the GMDN Agency's registration page - external site.

It is your responsibility to choose the most appropriate GMDN term for your medical device.

You need to:

• carefully consider all available GMDN terms, as sometimes there are multiple GMDN terms that could apply to your kind of device
• choose the most appropriate GMDN term for your type of device and how you intend it to be used
• document your rationale for selecting the GMDN term
• ensure your GMDN term is active on the GMDN Agency website when your sponsor applies to include your device in the ARTG.

Note

The TGA may reject an application for entry in the ARTG if the GMDN term used in the application is not the most appropriate Term. Application fees are non-refundable. Further information is available at: Refunds.

Case study

Example

Upkar plans to manufacture single-use tourniquet cuff bandages composed of both latex and non-latex materials. Upkar searches the GMDN Agency database using the search term 'tourniquet cuff bandage'.

He notes that:

• 'Tourniquet cuff bandage, Hevea-latex' and 'Tourniquet cuff bandage, non-latex' are separate GMDN terms.
• The definitions associated with these GMDN Terms specifically state that the devices are made from different materials.

So, although Upkar will manufacture single-use tourniquet cuff bandages with the same use, as they comprise different materials, they will be described by two (2) GMDN terms.

Using a GMDN term that includes the phrase 'custom-made'

You can use a GMDN term using the description 'Custom-made', even if your device is a 'patient-matched' device. GMDN terms are internationally agreed generic descriptors used to identify medical devices. The legal definitions for ‘custom-made’ and ‘patient-matched’ medical devices vary between jurisdictions. The phrase ‘custom-made' has a recognised meaning in everyday language. Generally, you can use the term 'custom-made' to indicate that a device is designed and manufactured to suit an individual.

For example, the most appropriate GMDN term for a patient-matched orthotic insole might be 'GMDN 62870 - Orthotic insole, custom-made'. In this instance 'custom-made' would simply mean a device personalised to meet an individual’s specific requirements and the description would cover both patient-matched medical devices and custom-made medical devices.

Requesting new GMDN terms

You should contact the GMDN Agency if you cannot find a suitable GMDN term to match the characteristics and intended purpose of your device. In some cases, the GMDN Agency will need to create a new GMDN term.

Alternatives to GMDN nomenclature terms

GMDNs are the only acceptable nomenclature terms that can be used for an application for inclusion of a kind of medical device entry in the ARTG.

Troubleshooting missing GMDN terms from TGA Business Services (TBS)

Your manufacturer should obtain its GMDN terms from the GMDN Agency - external site.

Email devices@tga.gov.au if the GMDN term you have received from your manufacturer is not available in TBS.

Misalignment of GMDN Agency list and TBS lookup tables

The TGA eBusiness Services (TBS) look up table does not always align perfectly with the GMDN Agency list. In many cases they have the same meaning or intent even though the wording in the GMDN term name and definition are different.

If the GMDN term provided to you by your manufacturer is significantly different from what is in TBS, your manufacturer should:

• use the applicable GMDN term from the GMDN Agency list
• send an email to devices@tga.gov.au advising of the issue.

Obsolete GMDN terms

If you come across an obsolete GMDN term in TBS, you should go back to your manufacturer. You should not apply using the obsolete GMDN term, as doing so may result in you losing your application fee.

Changing a GMDN term

GMDN terms can continue to be used throughout the life of a device while they remain appropriate for that device.

However, manufacturers sometimes want to change terms over time (for example, to replace obsolete terms or to replace terms with ones that are more relevant).

You will need to submit a change request or new ARTG inclusion application if your manufacturer wants to change the GMDN term supporting your kind of medical device entry in the ARTG.