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January 10, 2026
Approximately 5 minutes
Applying Global Medical Device Nomenclature (GMDN) Terms in Australia – TGA Requirements
Applying Global Medical Device Nomenclature (GMDN) Terms in Australia – TGA Requirements
What is GMDN and Why It Matters
The Global Medical Device Nomenclature (GMDN) is an internationally standardised generic naming system for medical devices, maintained by the GMDN Agency. It provides unique codes and terms to describe devices consistently across regulators, manufacturers, and healthcare systems. In Australia, accurate GMDN term selection is mandatory for all ARTG inclusions to:
- Facilitate device identification and traceability.
- Support correct classification and risk-based regulation.
- Enable effective post-market surveillance and vigilance.
- Align with international harmonisation efforts.
Incorrect or outdated GMDN terms can lead to application rejection, delays, or post-inclusion compliance issues. Source: Using Global Medical Device Nomenclature (GMDN) terms for medical devices - TGA
TGA Requirements for GMDN Use
- Mandatory for All ARTG Entries: Every device (including systems, procedure packs, and custom-made devices where applicable) must have an appropriate GMDN term and code.
- Most Specific Term Rule: Sponsors must choose the GMDN term that most precisely describes the device’s intended purpose, design, and key characteristics. Using a more general term when a specific one exists is not acceptable.
- Single GMDN per ARTG Entry: Each ARTG inclusion typically uses one primary GMDN term; variant devices may require separate entries if differences are significant.
- Verification During Application: TGA assesses the appropriateness of the selected GMDN during preliminary and full review. Sponsors must justify the choice if questioned.
- Ongoing Responsibility: If a GMDN term is retired or superseded, sponsors must apply to update the ARTG entry promptly.
How to Select and Apply GMDN Terms
- Access the GMDN Database: Use the GMDN Agency’s online portal (subscription required) to search for terms.
- Search Strategy:
- Start with keywords from the device’s intended purpose and features.
- Review term definitions, synonyms, and scope notes.
- Compare multiple candidate terms for best fit.
- Common Challenges:
- Avoid overly broad terms (e.g., “Medical device, general-purpose”).
- Ensure alignment between GMDN term, ARTG intended purpose statement, and labelling.
- For multi-function or combination devices, select the term reflecting the principal intended action.
- Submission in ARTG Application:
- Enter the 5-digit GMDN code and full term in the relevant fields.
- Provide justification if the choice is not obvious.
Consequences of Incorrect GMDN Use
- Application may fail preliminary assessment.
- TGA may request change or additional justification during review.
- Post-inclusion, incorrect terms can complicate vigilance, recalls, or international data sharing.
The TGA provides guidance notes, examples of correct vs. incorrect term selection, links to the GMDN Agency, and FAQs to assist sponsors in choosing appropriate GMDN terms for Australian regulatory compliance. Source: Using Global Medical Device Nomenclature (GMDN) terms for medical devices - TGA
Accurate GMDN application supports global harmonisation, improves regulatory efficiency, and enhances patient safety through better device identification in Australia.
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