Global Medical Device Nomenclature (GMDN)

What is GMDN?

The Global Medical Device Nomenclature, or GMDN, is a standardized system for naming, defining and grouping medical device product types. It gives regulators, manufacturers and healthcare organizations a common language for registration, data exchange, surveillance and procurement.

The nonprofit GMDN Agency maintains the nomenclature. Its official overview states that GMDN is used by around 70 national medical device regulators and by members in approximately 140 countries.

What is the difference between a GMDN Term and a GMDN Code?

A GMDN Term includes a Term Name, a five-digit Code and a Definition describing a group of devices with shared characteristics and intended use. The code is the identifier; it has meaning only when connected to the current term and definition.

GMDN is dynamic. Terms can be created, revised or made obsolete as technology and regulatory needs change. Manufacturers should use the current database rather than copying a code from an old submission or another company’s product. The GMDN official FAQs explain term access and enquiry processes.

Is a GMDN code a medical device risk class?

No. GMDN is a nomenclature system, while classification determines regulatory risk and controls. A device can have a GMDN code but still require a separate qualification and classification decision under each market’s law. Assignment of a code does not prove that a product is legally a medical device or that it has been authorized for sale.

How is GMDN different from EMDN and UDI?

GMDN and EMDN are different nomenclatures. The European Union uses EMDN for EUDAMED, so a GMDN code should not be presented as an automatic substitute. UDI serves another purpose: it identifies specific devices and production units for traceability, while a nomenclature groups similar device types.

Manufacturers entering the EU can review our EUDAMED registration guide. US manufacturers and labelers should see our FDA establishment registration and device listing guide.

Where is GMDN used?

Use and data-entry requirements vary by regulator. Official GMDN materials identify markets including the United States, Canada, the United Kingdom, Australia, Brazil and Colombia among users of the system. Manufacturers should verify whether a code is required, optional or mapped to another nomenclature in each target market. Relevant Pure Global country guides include Canada, Australia, Brazil and Colombia.