The use of GMDN codes according to the Australian regulatory system
Fact sheet no. 18
October 2006
GMDN codes
The Global Medical Device Nomenclature (GMDN) is a collection of terms each with a unique code number to describe and catalogue medical devices. GMDN was developed from the NKKN (Norwegian system), ISO Aids for the disabled, EDMA system for IVDs and the UMDN (ECRI) System by the International Standards Organisation and was published as ISO 15225.
GMDN Codes are available as a look up table within the TGA Device Electronic Application Lodgement (DEAL) form.
GMDN is a three tiered system consists of:
- 12 categories of devices
- Template terms -generic device groups identified with its unique code
- Preferred terms - identify product type (eg model and type). These are often grouped under the template term.
The 12 device categories
The 12 categories in the GMDN Code table are:
| Code | Term |
|---|---|
| 01 | Active implantable devices |
| 02 | Anaesthetic and respiratory devices |
| 03 | Dental devices |
| 04 | Electro-mechanical devices |
| 05 | Hospital hardware |
| 06 | In vitro diagnostic devices |
| 07 | Non-active implantable devices |
| 08 | Ophthalmic and optical devices |
| 09 | Reusable instruments |
| 10 | Single use devices |
| 11 | Technical aids for disabled persons |
| 12 | Diagnostic and therapeutic radiation devices |
Template terms
Template terms are broad names that group similar preferred terms. A template term followed by the word <specify> eg; forceps <specify> indicates that there are a number of preferred terms grouped under this template term. Only Class I medical devices may be included on the Australian Register of Therapeutic Goods (ARTG) by the template term and its unique 5-digit code number.
Preferred terms
Preferred terms represent a type of device that has the same or similar intended purpose or common technology. Eg: forceps bone, forceps biopsy, forceps lung.
It is important to ensure that the definition of a preferred term accurately describes the device. If not an alternative search may be needed to find the most appropriate GMDN term for the device.
Class I devices that have a measuring function or are supplied sterile, Class IIa and IIb medical devices are identified and included on the ARTG by the preferred term.
Class III and Active Implantable Devices (AIMDs) are identified and included on the ARTG using the preferred terms and an additional unique product identifier. This additional identifier is not part of the GMDN Coding system and is issued by the manufacturer to describe a device and any variants of the device that provide for different patient anatomy.
Synonym terms
A Synonym term is a term from a previous coding system that is cross-referenced to a preferred term identified by the international steering committee for the GMDN. Synonym terms are identified by a 5-digit number in the Synonym column of the GMDN Code table and do not have a definition as demonstrated in the example below.
When a synonym term is selected, the DEAL system will default to the preferred term or the appropriate template term. Again it is important to ensure the definition for the preferred term is the most appropriate to describe the device.
Unclassified terms
An unclassified term (code 38442) can be used as a last resort if no accurate GMDN term is available to describe the device. However its use will trigger a TGA application audit so that an appropriate existing GMDN term can be identified or a new term created.
Example of the GMDN Code Table
The following table is an extract from the GMDN tables to demonstrate the form and workings of the GMDN Coding System.
Using GMDN codes in the ARTG
ARTG - Kind of Medical Device
This chart illustrates how the GMDN codes are used in the ARTG. The detail held, increases with classification:
| Class I 12340 Light for medical use 35079 Forceps |
|
Class I devices (other than those that are supplied sterile or have a measuring function) are identified by the Template term which may be followed by the. The word <specify> |
| Class IIa and IIb 16668 Burr, dental, carbide 16669 Burr, dental, steel 16670 Burr, dental, diamond |
|
Class I devices supplied sterile, or that have a measuring function, Class IIa and Class IIb require the specific preferred term. |
| Class III and AIMD 34615 Dressing, absorbable, collatape 34615 Dressing, absorbable, Collacole 34615 Dressing, absorbable, collaplug |
|
Class III and AIMDs have an additional unique product identifier determined by the manufacturer. This additional descriptor is not part of the GMDN Coding system. |
NB Manufacturers are best placed to determine the correct GMDN Code and sponsors are urged to seek the advice of the manufacturer and the manufacturer's Declaration of Conformity in order to ensure the GMDN Code is correct.
For further assistance on GMDN Codes please refer to the GMDN website <http://www.gmdnagency.com>.
Disclaimer
This document is provided for guidance only. It should not be relied upon to address every aspect of relevant legislation. Please refer to the Therapeutic Goods Act 1989 as amended by the Therapeutic Goods Amendment (Medical Devices) Bill 2002 and the Therapeutic Goods (Medical Devices) Regulations 2002 for legislative requirements.
© Commonwealth of Australia 2006