Introduction to Global Medical Device Nomenclature (GMDN)

Why we use GMDN Terms

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.

Guidance for manufacturers

Where to find GMDN Terms

GMDN Terms are provided by the GMDN Agency website.

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.

Choosing the most appropriate GMDN Term

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, and
• ensure your GMDN Term is active on the GMDN Agency website when your sponsor applies to include your device in the ARTG.

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.

Guidance for sponsors

Troubleshooting missing GMDN Terms from TGA Business Services (TBS)

Your manufacturer should obtain its GMDN Terms from the GMDN Agency.

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.

Relevant legislation

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