The Global Medical Device Nomenclature (GMDN) is a system of internationally agreed descriptors used to identify medical device products. The GMDN Database lists all the terms, which are currently available to name and describe medical devices, although new terms are regularly issued to cope with new medical devices innovations. The GMDN is owned and managed by the GMDN Agency, a non-profit organisation. To find out more about the GMDN and its history, visit our About Us section.  

The GMDN Agency is a registered UK charity and non-profit organisation responsible for the ongoing maintenance of the GMDN database. The Agency was established to provide health authorities and Regulators, healthcare providers, Manufacturers and others with a system that allows an exchange of medical device information and supports patient safety.

Our vision is: To provide a single common language for all medical technology, and for it to be adopted by medical device Regulators, Manufacturers and other participants in healthcare systems worldwide.

Our mission is: To be the global leader in naming, describing and unambiguously identifying medical devices for the protection of patients

Read more about our vision and objective in our 5 year strategy.

You can download our latest annual report from the Charities Commission website.

Anyone can register for free as a member on the GMDN website to access and use any GMDN term. Registered members can check their GMDN Term status at any time without charge. The full GMDN is available for free to Regulators, healthcare providers and academic researchers.

Device Manufacturers can choose to register for a paid notification service that can save them time in managing the GMDN terms they use. Certain qualified members, such as governments, hospitals, and academics, can register to obtain full sets of GMDN terms updated regularly without charge.

Access to GMDN is open to anyone in any country and allows members to access all term names, definitions, and codes, view proposed new changes to terms, provide comments, and ask questions.

All members must register to preserve the database's integrity and security, allowing direct communication and meeting regulatory requirements. Registration supports data integrity, timely updates, and global contributions. This is the same requirement to register on the WHO website to see the WHO-FIC (ICD-11 draft items).

If you are part of an international group of companies, we recommend you only have one GMDN account and therefore can be globally consistent in your selection of GMDN Terms for your entire product range. Please contact us for assistance and to work out the best membership and account use option for your organisation.

The GMDN Agency is a UK charity and a non-profit organisation and is responsible for creating and maintaining the GMDN database.

GMDN Term names and definitions are freely available to all members, allowing them to find the most appropriate term and related code.

The full GMDN is available for free to Regulators, healthcare providers and academic researchers.

Medical device Manufacturers can choose to register for a paid membership to better manage their company's GMDN Terms, which is the only source of income for the agency. Paid membership is an option for only medical device Manufacturers, consultancy organisations, and other commercial organisations.

The GMDN has approximately 15,000 members, with 91% on basic (free) membership. The membership structure ensures that no member contributes more than 2% of the GMDN Agency’s income, ensuring the agency's independence.

GMDN has members across 145 countries, making it the most widely used, global nomenclature, helping regulators, medical device sector and researchers to communicate with one another accurately.

Governments using GMDN (74 as of April 2023):

• Argentina
• Armenia
• Australia
• Austria
• Bahrain
• Belarus
• Belgium
• Bhutan
• Bosnia and Herzegovina
• Brazil
• Bulgaria
• Canada
• Chile
• Colombia
• Costa Rica
• Croatia
• Cuba
• Czechia
• Denmark
• Ecuador
• Estonia
• Ethiopia
• France
• Ghana
• Indonesia
• Ireland
• Italy
• Japan
• Kazakhstan
• Kenya
• Kyrgyzstan
• Latvia
• Lebanon
• Malaysia
• Mexico
• Mexico
• Montenegro
• Nepal
• Netherlands
• New Zealand
• Nicaragua
• North Macedonia
• Norway
• Oman
• Pakistan
• Panama
• Peru
• Poland
• Portugal
• Qatar
• Republic of Moldova
• Russian Federation
• Rwanda
• Saudi Arabia
• Senegal
• Sierra Leone
• Singapore
• Slovenia
• South Africa
• Spain
• Sudan
• Sweden
• Switzerland
• Taiwan
• Tajikistan
• Thailand
• Tunisia
• Türkiye
• Uganda
• Ukraine
• United Kingdom of Great Britain and Northern Ireland
• United Republic of Tanzania
• United States of America
• Venezuela
• Vietnam

The GMDN Agency owns the copyright to the GMDN as this helps us protect and maintain the integrity of the data ensuring that any publicly available data is accurate, up to date and supports patient safety.

We have several licensing agreements with many Governmental Regulators, including the United States of America's FDA, the UK’s MHRA and Australia’s TGA, to publish the GMDN to support patient safety.

If you want to know more about how we can work together, please contact us

Access to GMDN is open to anyone in any country and allows members to access all term names, definitions, and codes, view proposed new changes to terms, provide comments, and ask questions.

All members must register to preserve the database's integrity and security, allowing direct communication and meeting regulatory requirements. Registration supports data integrity, timely updates, and global contributions. This is the same requirement to register on the WHO website to see the WHO-FIC (ICD-11 draft items).

After joining the GMDN, Terms and Codes are found on our website using a simple search tool. Please go to the Services menu on the website for more information.

No, the GMDN Agency is not a Medical Device Regulator. We make available the generic GMDN Terms to standardize the naming and grouping of medical devices. This improves communication within the health-sector and helps Regulators better understand information about medical device use.

Medical Device Regulators specify the use of the GMDN to meet their national requirement. For example, in the USA the FDA require the GMDN as part of their UDI Rule. The medical device Regulators in over 90 countries are using the GMDN to support patient safety and often require the GMDN Code attribute in their medical device listing or approval process.

The GMDN Term is made up of several data elements, including the Term Name, GMDN Code and a Definition. As seen in this example:

- Term Name: 'General-purpose syringe'
- GMDN Code: '47017'
- Definition: 'A sterile device consisting of a calibrated barrel (cylinder) with plunger...'.

Using the GMDN Database members can search all the Term Names and Definitions for the appropriate description of their product. Once selected, the GMDN Code is made available to the member and then used for regulatory or data exchange purposes. Selected Codes are automatically added to the members 'My Terms' list for future reference and tracking for status changes by us.

New terms are issued regularly following requests from members who are developing new technology or due to feedback from medical device Regulators. The GMDN Database is updated daily. Certain account types are informed by email if a term in their 'My Terms' list is modified or made obsolete.

A GMDN Term Name or Definition may need to be modified to expand its scope or the Term may be made obsolete if it no longer accurately represents a product group. Certain account types with these particular Terms in their 'My Terms' list will be notified automatically by email, so that they can consider whether or not to choose an alternative Term for their product. All members can check the status of a GMDN Term by entering the GMDN Code in our search engine.

The GMDN is a dynamic database that reflects the dynamic nature of the medical devices sector. New Terms are added regularly to keep the nomenclature up to date with current medical technology. The database is updated daily, and members are notified via email if a term in their "My Terms" list is modified or made obsolete.

New Terms are added to prevent overlap or duplication of terms and are necessary to fit new products into the nomenclature. Terms are also expanded to cover slight variations of products, and wording changes are made to ensure consistency.

Obsoleting Terms is necessary as new technology may require an existing Term's scope to be divided into two or more sub-categories, and legacy Terms that are no longer used are removed to eliminate redundancy. These changes may cause short-term disruption, but replacement Terms are easily found on the GMDN website.

Yearly average changes in GMDN as follows (as of March 31st, 2023):

• New Terms: 2.12%
• Term Obsoleted: 1.98%
• Terms Amended: 5.08%
• Total GMDN Terms 24,910
• Yearly average change rates have been consistent in the last three years (2021-2022-2023)
• 877 enquires raised by the Manufacturers (01/04/2022-31/03/2023)

The GMDN Agency has a team of technical experts who create descriptions for medical devices. They follow a process to ensure the language used is clear and consistent.

New products need to be added to the existing set of descriptions in a way that prevents duplication of Terms. If a product is truly unique, it is straightforward to add a new Term. If a new product is a variant of an existing product, an amendment may be allowed, but only if the scope of the Term is not reduced.

Occasionally, the GMDN Agency may need to review Terms to ensure they are up to date with current technology. If a Term is no longer relevant, it may be made obsolete. Obsolete Terms remain available for reference purposes.

Updating of the GMDN is monitored and controlled by an ISO9001 Quality Management System. Our QMS is annually audited by a third-party Certification Body. GMDN Agency has been certified by BSI to ISO 9001:2015 under certificate number FS 639464. Our certification can be authenticated on the BSI Directory of Certified Clients.

The GMDN Agency has internal QMS and SOPs regarding term development, management of enquiries, and management of conflicts.

If you can't find a Term that is appropriate for your product, you can request assistance from the GMDN Agency. We have a free on-line enquiry service that will review your product and the relevant existing GMDN terms. The GMDN Agency will review your request and determine if a new Term is required or an existing Term may need to be modified or an existing Term may be suitable. When sending an enquiry, please include as much information about the product as possible. The enquiry process is complex and can take several weeks to complete, so please give us plenty of time to consider your enquiry. But please let us know if your need is urgent.

Regulators and Conformity Assessment Bodies know the process for new Term requests used by the GMDN Agency and may accept a delay in providing a GMDN Code depending on their individual requirements, provided an enquiry for a new Term has already been made. Please let us know if your enquiry is delaying your product registration and we will try to assist.

All client information contained in the GMDN Database is password protected, encrypted and not available to any other member. Under strict controls we are required to share some client information with Medical Device Regulators, including the identification of GMDN Codes selected by Manufacturers and which appear in the 'My Terms' list.

The GMDN Codes are protected so that most members can only see codes relevant to their product range. This is done by the member searching the GMDN database until they find the most appropriate GMDN Term for their product. Members can see all 24,000+ GMDN Terms in the database. The member can then use a Code Credit to reveal the related GMDN Code (this is a 5-digit number). We provide all basic member accounts with 50 Code Credits when you join. Other membership types have more Code Credits, you can view our membership types at this link.

Multi-user access is managed within the GMDN database by the 'Users' function, found in the 'Account' menu. The Users function is restricted to users with a specific permission on their GMDN membership account and may also be restricted by account type - please contact us for more information.

If a member wishes to change the GMDN Code selected for a particular product, it is recommended that they discuss this with their Regulator or Conformity Assessment Body. Please contact us if you have any concerns. If members no longer want us to monitor a Term in their 'My Terms' list, this can be moved to their 'My Archive' list.

The Manufacturer is responsible for assigning the correct GMDN Term to their device because they understand their device most comprehensively.

The GMDN Agency provides training to Manufacturers through an online module, user guides, webinars, and a code of good practice.

The GMDN is also building a new tool to help manufacturers find replacement terms when a term becomes obsolete.

The GMDN provides feedback on assignments to Manufacturers through its membership contacts and supports them through the GMDN enquiry service.

The reference language of the GMDN is English. Terms and Definitions are translated into many languages and your preference can be chosen from the main menu. A list of current languages is below:

• Bulgarian - български
• Chinese (simplified) - 简体中文
• Chinese (traditional) - 繁體中文
• Croatian - Hrvatski
• Czech - Čeština
• Danish - Dansk
• Dutch - Nederlands
• English
• Estonian - Eesti
• Finnish - Suomi
• French - Français
• Gaelic - Gaeilge
• German - Deutsch
• Greek - Ελληνικά
• Hungarian - Magyar
• Italian - Italiano
• Japanese - 日本語
• Korean - 한국어
• Latvian - Latviešu
• Lithuanian - Lietuvių
• Maltese - Malti
• Norwegian - Norsk
• Polish - Polski
• Portuguese - Português
• Portuguese (Brazilian) - Português (Brasileiro)
• Romanian - Română
• Russian - Русский
• Slovak - Slovenčina
• Slovenian - Slovenščina
• Spanish - Español
• Swedish - Svenska
• Turkish - Türkçe
• Ukrainian - Українська

     

GMDN Codes are not built into the Static UDI number allocated to your product and therefore changes to GMDN Terms will not require you to assign a new UDI to your product and the costly relabelling that would result.

As part of their implementation of UDI, the US FDA require manufacturers to submit a GMDN Code that is not obsolete, when you provide your product information as part of the GUDID record submission. We have been informed by the FDA that it is possible to change the GMDN Code allocated to a product on the GUDID at any time, because the GMDN record is not ‘locked’ unlike other information, such as the Static UDI number.

If a product has been assigned a GMDN Code it is not necessarily a medical device. Please refer to the regulation that applies to medical devices in your country of interest. It is envisaged that the use of the GMDN by all countries will support the harmonisation of the definition of a medical device worldwide.

The FDA/NLM is adding new functionality to AccessGUDID and OpenFDA as regards the GMDN, namely that the GMDN Code and status (active or obsolete) will be displayed against each product record (along with the currently displayed name and definition).

The FDA state: “If a labeller submitted an FDA Preferred Term (FDA PT) Code to meet their GMDN Code data entry requirement, the equivalent GMDN Code will now also be released publicly”. So, following this launch PT code users can register with GMDN and switch to using the GMDN code.

If you want to check the status of the GMDN Terms that you are using (and find the corresponding GMDN Codes by linking to your account) prior to the new AccessGUDID launch, then you can search the GMDN database using the GMDN Term Name. Simply:

• Register with GMDN
• In search click ‘Advanced’ and ‘Include Obsolete’
• Enter the term name and search

No, the GMDN is not intended to be on the packaging for several important reasons. The definitions are in depth, the GMDN is published in over 25 languages, and it would take up too much space on the packaging. Also, these technical descriptions are subject to change over time as new medical innovations become available and are therefore dynamic in nature.

We recommend you talk to your suppliers and get the relevant GMDN Terms and Codes from them. This will make sure the GMDN Terms you use are consistent with other distributors in the market. Many manufacturers are licensee members of the GMDN Agency.