Since 1991 Medical Device experts from around the world (regulators, healthcare providers and manufacturers) have worked together to create the Global Medical Device Nomenclature (GMDN). This work was requested by the inter-governmental body, the Global Harmonisation Task Force (GHTF) to help accelerate international medical device regulatory harmonization and convergence. The GHTF has now been superseded by the IMDRF (see www.imdrf.org).
The GMDN Agency is the non-profit organisation that is responsible for the ongoing maintenance of the GMDN. It is a registered UK charity, subject to an independent audit each year and regulated by the UK Charites Commission. Our Annual Report is available from the Charities Commission website.
The Agency’s objects are:
To preserve and protect health and to relieve sickness for the public benefit by developing and maintaining the “Global Medical Device Nomenclature”, a system of internationally agreed descriptors used to identify medical device products which will meet a global need for identification purposes.
The GMDN Agency has a Board of Trustees.
The Policy Advisory Group provides advice to the Board of Trustees on matters of relevance to the satisfactory maintenance of the GMDN, including:
For more information about the PAG, please contact us in writing.
Independence and trust are important values for the GMDN Agency. We work with medical device regulators, manufacturers, healthcare providers and their representative bodies to ensure we understand and respond to their needs and to promote international harmonisation of medical device standards and regulation.
The GMDN Agency is a member of the following organisations or we have signed a Memorandum of Understanding or licence or similar document.
In addition, the GMDN has been licenced for use to the government of the following countries: