Global Medical Device Nomenclature - GMDN

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More information is available from:

Database of Adverse Event Notifications

19 June 2013

The Global Medical Device Nomenclature (GMDN) is an international system used to identify and classify medical devices. The TGA use the GMDN system as one of the criteria to distinguish one kind of medical device from another.

GMDN structure

The GMDN system has a general structure of three levels. The three levels are connected and are in the order of:

  1. device category,
  2. generic device group and
  3. device type.

GMDN code and term

GMDN codes and terms allow medical devices with similar features to be identified and are used by the TGA to assist in the:

  • consistent assessment of medical devices before they are approved for supply
  • ongoing monitoring of medical devices once they are available for supply
  • exchange of post market vigilance information between regulatory bodies.

All medical devices entered on the Australian Register of Therapeutic Goods (ARTG) will have an associated GMDN code and term.

The Database of Adverse Event Notifications - medical devices allows users to search the database using a GMDN term.

Example:

GMDN Term: Pacemaker, Cardiac, implantable
GMDN code: 12913

The GMDN Agency

The GMDN database is maintained by the GMDN Agency, a not for profit agency based in the United Kingdom. The GMDN agency collaborates with various technical experts from around the world to update the database in alignment with technological advancements.

The GMDN was developed as a result of a mandate given by the European Commission. The original GMDN system was compiled by medical device experts from around the world.