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Working Towards Harmonization
in Medical Device Regulation

GHTF > About GHTF > Position Statement: Single Global Nomenclature System for Medical Devices

Position Statement: Single Global Nomenclature System for Medical Devices

One of the key elements in working to achieve a globally harmonised approach to the regulation of medical devices is the use of a single nomenclature system that is readily available globally for regulatory purposes. The members of the GHTF are committed to having a single global nomenclature system for medical devices.

The nomenclature of a medical device facilitates its progression through the entire product life cycle. The use of a single system would enable consistency in classification and identification, the consistent capture of product information across manufacturers, sponsors, distributors and in the clinical setting, for example, in hospitals. It would streamline medical device recalls, adverse event reporting and postmarket surveillance and monitoring.

The GMDN is a system of internationally recognised coded descriptors used to generically identify medical devices, which is now being utilised by many of the world’s medical device regulators and industry. The GHTF therefore endorses the GMDN coding system as the preferred nomenclature system for regulatory purposes for medical devices and will continue to work to ensure its effective governance and availability.

Updated 19 November 2010

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