Global Medical Device Nomenclature

What Global Medical Device Nomenclature does

The GMDN Agency Ltd is a UK-registered charity (1154418) and company limited by guarantee, founded in 2005, that maintains the Global Medical Device Nomenclature (GMDN), the internationally agreed terminology for naming and classifying medical devices. Its core product is the GMDN Database, a purpose-built proprietary database and search engine containing over 25,000 Terms, 5-digit GMDN Codes, Definitions, and Categories covering general medical devices and in vitro diagnostics. The database is curated by a Term Development Team under an ISO 9001 Quality Management Procedure, with extensions including the new GMDN-SNOMED CT Extension (jointly developed with SNOMED International, January 2026) and Category Versioning (launched April 2026). Advanced tooling includes an autocorrection facility, an Advanced Search function (November 2024), and integration with procurement systems such as the GHX Master Catalog.

GMDN is adopted by regulators in 140+ countries, including the US FDA, UK MHRA, Australian TGA, Brazilian ANVISA, and Health Canada, with the UK NHS approving it in 2023 as a fundamental standard for device identification. The Agency serves seven distinct customer segments: medical device manufacturers, government regulatory bodies, public healthcare providers, conformity assessment bodies, academic researchers, basic users, and consultancies. Approximately 13,000 members across 140+ countries use GMDN, with roughly 90% on free basic membership and the remainder on paid tiers.

The revenue model is a hybrid freemium/subscription structure. Basic, Government, Healthcare Provider, and Academic Researcher memberships are free; paid annual subscriptions are offered to Manufacturers, Consultancies/Commercial Organisations, and Conformity Assessment Bodies. A transaction fee of £105 applies to enquiry submissions for Basic and Consultancy members, while Regulators, Healthcare Providers, and Manufacturer members receive unlimited free priority enquiries. No single member contributes more than 2% of agency income, preserving independence. Distribution is direct via the members.gmdnagency.org portal and public gmdnagency.org website, with no resellers, and the GMDN Agency has no parent company or subsidiaries.

Name

Global Medical Device Nomenclature

Legal name

GMDN Agency Ltd

Website

https://gmdnagency.org

Company type

Private

Founded year

2005

Operating status

Operating

Headcount range

11–50 employees

Short description

The GMDN Agency is a UK-registered charity that maintains the Global Medical Device Nomenclature, a curated database of 25,000+ standardised device terms used by regulators, manufacturers, and healthcare providers across 140+ countries.

Ownership category

akta.pro rank

Product category

Medical Device Nomenclature and Terminology Standards

NAICS

Computing Infrastructure Providers, Data Processing, Web Hosting, and Related Services (518)

SIC

Services-Computer Programming, Data Processing, Etc. (7370)

akta.pro primary industry

Healthcare Terminology, Ontology & Code Set Management (SNOMED/LOINC/ICD/RxNorm) (HLACAIAF)

akta.pro secondary industries

Healthcare Master Data Management (MDM) & Patient/Provider Identity Data (HLACAIAB), Data Privacy, Consent & Compliance Management (HDAEADAG)

Keywords

• Medical device nomenclature
• Medical device classification
• Regulatory terminology database
• Health data standards
• Medical device coding

Headquarters

HQ city

Oxford

HQ country

United Kingdom

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Software

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Manufacturer Paid Memberships: Annual paid membership fees from medical device manufacturers and commercial organisations providing tools for operational efficiency, regulatory support, term management, unlimited enquiries, data download, and access to proposed terms. No single member contributes more than 2% of the agency's income.
2. Consultancy & Commercial Organisation Memberships: Annual paid licence fees for consultancies and commercial organisations providing services to medical device manufacturers, subject to email verification.
3. Enquiry Service Charges: Charges for enquiry submissions: Basic members charged £105 per enquiry; Consultancy/Commercial members receive 2 free enquiry credits, subsequent enquiries charged at £105 per submission. Regulators, Healthcare Providers and Paid Manufacturer members receive unlimited free priority enquiries.
4. Conformity Assessment Body Memberships: Annual paid membership fees for conformity assessment bodies (e.g., European Notified Bodies, Government Inspectors), subject to email verification.

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels8 records

Core offering

The GMDN Agency maintains and licenses the Global Medical Device Nomenclature, a proprietary database of over 25,000 Terms, 5-digit GMDN Codes, Definitions, and Categories used to identify, classify, and categorise medical devices for regulatory submissions, supply chain, procurement, and post-market surveillance. Access is delivered through a licensed web-based Members Portal with tiered membership (free for regulators and healthcare providers; paid for manufacturers, consultancies, and conformity assessment bodies) and supported by a Term Enquiry Service, data downloads, and training.

Product overview

The GMDN Agency operates a single unified nomenclature database (the GMDN Database) containing over 25,000 Terms, 5-digit GMDN Codes, and Definitions for identifying and classifying medical devices globally. Access is delivered through a licensed web-based Members Portal and supports multiple membership tiers: Basic (free with limited codes), Manufacturer, Consultancy, Government Department, Public Healthcare Provider, Conformity Assessment Body, and Academic Researcher. Paid tiers unlock advanced features including Advanced Search, My Terms management, Notifications, Unlimited Enquiry Service, Data Download, and Training. The GMDN Database underpins regulatory compliance, procurement, supply chain management, and post-market surveillance across 140+ countries.

Differentiator

Problem solved

Functional benefit

Products and services

• GMDN Database The internationally agreed database comprising GMDN Terms, 5-digit GMDN Codes, Definitions, and Categories (Collective Terms) used to identify and classify medical devices for regulatory submissions, supply chain management, procurement, and post-market surveillance. Used by regulators, manufacturers, healthcare providers, and conformity assessment bodies worldwide.
• GMDN Members Portal Licensed web-based portal providing authenticated access to the GMDN Database via user ID and password, supporting term searches, code management, category browsing, notifications, and enquiry submission for licensed members.
• Term Enquiry Service Service enabling members to request assistance with identifying appropriate GMDN Terms, assessing whether existing term definitions need modification, or requesting creation of new terms for product variants. Basic members are charged £105 per enquiry; consultancy members receive 2 free credits.
• GMDN-SNOMED CT Extension Jointly developed extension with SNOMED International that strengthens the connection between clinical and regulatory medical device data, replacing the existing SNOMED CT-GMDN linkage table for more robust interoperability across health systems, regulators, and industry.
• Training and Workshop Sessions Quarterly online training sessions and on-demand workshops for GMDN manufacturer members, including video tutorials and user guides for database navigation, term assignment, and membership maximisation.

Quantifiable outcome

• GMDN is adopted in over 140 countries by regulators, manufacturers, healthcare providers, and procurement bodies.
• +4 more outcomes

Named customers4 records

Segments7 records

Ideal customer profiles6 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Eight partnerships are on record, tiered major and core.

• Kazakhstan Medical Device AuthoritymajorStrategic or Co-development Partner · 8 June 2026GMDN Agency signed a cooperation agreement with the Kazakhstan medical device authority to support the use of GMDN in Kazakhstan's regulatory framework.
• Global Healthcare Exchange (GHX)coreStrategic or Co-development Partner · 3 February 2026Collaboration to integrate GMDN data into GHX's extensive hospital network across the United States and Canada. GMDN data will be embedded into the GHX Master Catalog to support enhanced data enrichment, procurement, and clinical analytics. Partnership aims to improve accuracy and efficiency of medical device data management and strengthen supply chain resiliency.
• SNOMED InternationalcoreStrategic or Co-development Partner · 30 January 2026Strategic collaboration to jointly develop and maintain a GMDN–SNOMED CT Extension, replacing the existing SNOMED CT–GMDN linkage table with a more robust, sustainable, and interoperable solution. The extension aims to improve medical device content coverage, quality, and usability while supporting harmonised implementation across health systems, regulators, and industry. Both organisations are members of the Joint Initiative Council for Global Health Standardization.
• UK Department of Health and Social Care (DHSC)coreStrategic or Co-development Partner · 12 September 2025Umbrella collaboration agreement to further embed GMDN into all regulatory databases, Medical Device Data programmes, and NHS programmes across the UK. GMDN will continue to be integrated into MHRA regulatory databases and will play a crucial role in upcoming Medical Device Data programmes including the Product Information Management system (PIM) within the NHS.
• Joint Initiative Council (JIC) for Global Health Informatics StandardisationcoreStrategic or Co-development Partner · 4 March 2025GMDN Agency became a member of the JIC, joining a coalition of standards development organisations dedicated to harmonising health informatics standards. JIC works to address gaps and overlaps in standards, foster collaboration among international health informatics SDOs, and achieve widespread adoption of harmonised standards worldwide.
• MEEMPA (Medical Electrical Equipment Maintenance Professionals Association)majorStrategic or Co-development Partner · 19 February 2025Partnership with MEEMPA for the Arabic translation project of the GMDN Medical Device Nomenclature, funded by the Literature, Publishing, and Translation Commission of the Kingdom of Saudi Arabia. MEEMPA Chairman Ing. Omar Alsohime led the project launch at the International Healthcare Technology Management Conference in Riyadh.
• World Health Organisation (WHO)coreStrategic or Co-development PartnerOngoing collaboration with WHO to support the Model Essential Diagnostics List (EDL), with corresponding GMDN Terms and Categories accessible at edl.who-healthtechnologies.org. GMDN Agency continues to support efforts to keep the WHO Model EDL updated with relevant GMDN data.
• International Medical Device Regulators Forum (IMDRF)coreStrategic or Co-development PartnerCollaboration with IMDRF and Global Harmonised Working Party (GHWP) to reduce regulatory burden, improve data quality, and support better health outcomes through common nomenclature. IMDRF terms are implemented in regulatory systems globally.

Scale indicators9 records

Recent moves7 records

Expansion highlights7 records

Others

• ICD (WHO International Classification of Diseases): ICD is the WHO's global standard for diagnostic health classification and is comparable as an internationally mandated health terminology standard. It is a peer in the broader health-terminology ecosystem and a collaborator of GMDN through the WHO Model Essential Diagnostics List work.
• GS1 (UDI and supply chain standards): GS1 maintains the GTIN and UDI standards used in medical device identification and supply chain labelling. It is comparable as an adjacent healthcare data and identifier standard, and increasingly intersects with GMDN in UDI and procurement workflows.
• LOINC (Logical Observation Identifiers Names and Codes): LOINC, maintained by Regenstrief Institute, is the dominant terminology for laboratory and clinical observations, including in vitro diagnostics. It is a peer terminology standard with overlap to GMDN in the IVD and diagnostic testing categories.
• GUDID (FDA Global Unique Device Identification Database): GUDID is the FDA's regulatory UDI database that relies on GMDN terms for device classification. It is an adjacent infrastructure rather than a direct competitor — it is a consumer of GMDN data — and a key channel for GMDN's regulatory adoption in the US market.
• EUDAMED (European Database on Medical Devices): EUDAMED is the EU's central medical device database, which mandates EMDN nomenclature for device registration. It is an adjacent regulatory infrastructure and the principal route by which EMDN — GMDN's main competitor — has achieved mandated status in the European market.
• UNSPSC (United Nations Standard Products and Services Code): UNSPSC is a general procurement and supply chain classification maintained by the UN. It is a tangential competitor in healthcare device classification, selected by only 3% of GMDN 2024 survey respondents, but it is occasionally used in hospital procurement contexts where GMDN is not mandated.

Direct peers

• UMDNS (Universal Medical Device Nomenclature System): UMDNS, maintained by ECRI, is an older medical device nomenclature still in use in some hospital systems, particularly in North America. It competes with GMDN in the same terminology category and was selected by 5% of GMDN 2024 survey respondents over GMDN, indicating a niche but persistent installed base.
• SNOMED International: SNOMED International maintains the SNOMED CT clinical terminology, a peer and now strategic collaborator through the GMDN–SNOMED CT Extension announced in January 2026. It is the most relevant peer because it is the dominant clinical-health terminology system and GMDN's bridge into clinical decision support and EHRs depends on it.
• MedDRA (Medical Dictionary for Regulatory Activities): MedDRA is the ICH-endorsed terminology for adverse event reporting and regulatory safety surveillance across drugs, biologics, and devices. It is comparable to GMDN as a regulated medical terminology standard with mandated use in regulatory workflows, and a partial overlap exists in device-related safety reporting.
• European Medical Device Nomenclature (EMDN): EMDN is the nomenclature mandated for EUDAMED submissions in the European Union and is the closest direct competitor to GMDN. Although 70% of survey respondents prefer GMDN, EMDN is required for EU regulatory filings, making it the primary substitute in the world's largest medical device market.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/@gmdnagency2512/featured
• LinkedInlinkedin.com/company/gmdn-agency

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Global Medical Device Nomenclature