A Global Medical Device Nomenclature, or GMDN, code provides a standardised way of identifying a generic type of medical device or in vitro diagnostic medical device, or IVD.
For companies operating in South Africa, GMDN codes have a direct regulatory purpose. SAHPRA’s medical device establishment licensing guideline requires applicants to provide a list of devices by product classification together with the applicable GMDN codes as part of relevant manufacturer and distributor licence applications.
Finding a code, however, should not be treated as a simple keyword search.
The correct GMDN term should accurately describe the device’s intended purpose and relevant characteristics. Selecting a term simply because its name sounds similar to the commercial product name can result in a code that does not properly describe the device.
For South African regulatory submissions, the practical objective is therefore not merely to find a GMDN code. It is to identify the most appropriate active GMDN term for the device being supplied and ensure that it remains consistent with the device’s intended purpose, classification and product listing.
What is a GMDN code?
The Global Medical Device Nomenclature is an internationally used system for naming and categorising medical devices.
Each individual GMDN Term is identified by a unique five-digit code.
A GMDN assessment should consider three connected elements:
- the GMDN Term Name;
- the GMDN Code; and
- the GMDN Definition.
The definition is particularly important because it describes the intended use and relevant characteristics of devices captured by the term.
A manufacturer should therefore avoid choosing a code based only on the term name.
Why does SAHPRA use GMDN codes?
Medical device regulators need a consistent way of describing thousands of different types of medical devices.
Commercial product names are unsuitable for this purpose because the same type of device can be sold under multiple brands and product names.
SAHPRA’s establishment licensing guidance requires relevant product listings to identify medical devices or IVDs together with their Global Medical Device Nomenclature codes.
GMDN therefore provides a standardised regulatory description of the device type and should be treated as regulatory data rather than an internal stock code.
What information forms part of a GMDN term?
A GMDN term contains more than the five-digit number commonly entered into a regulatory spreadsheet.
The Term Name provides the generic name of the device type.
The GMDN Code provides the unique five-digit identifier.
The Definition describes the intended use, application and important characteristics of the devices included within that term.
All three should be considered when determining whether the term accurately describes the manufacturer’s device.
GMDN code and SAHPRA classification are not the same thing
A GMDN code identifies the generic type of medical device.
A SAHPRA classification determines the regulatory risk class of the device.
South Africa uses Classes A, B, C and D.
The two pieces of regulatory information should be consistent, but one does not replace the other.
For risk classification, see Medical Device Classification in South Africa: Classes A, B, C and D.
Where are GMDN codes used in South Africa?
One of the principal uses is medical device establishment licensing.
GMDN information can therefore form part of new licence applications, product-list preparation, portfolio reviews and ongoing regulatory maintenance.
GMDN also featured prominently in SAHPRA’s 2024 Medical Device Registration Voluntary Feasibility Study, where product categories and certain eligible products were identified using GMDN categories, terms and codes.
This indicates that accurate GMDN information can also be relevant to future registration readiness.
How to access the GMDN database
The authoritative source for GMDN information is the GMDN Agency.
The normal process is to register, access the search functionality, identify terms relevant to the device, review their definitions and obtain the associated code.
Manufacturers should use the authoritative database rather than relying on old spreadsheets, distributor databases or codes copied from unrelated products.
How to find the right GMDN code
A reliable search process starts with understanding the medical device.
Before searching, identify what the device is, what it is intended to do, how it works and the characteristics that distinguish it from similar devices.
Relevant characteristics can include whether the device is sterile, reusable, single-use, active, invasive, an IVD, an accessory or part of a wider system.
This information allows the search to focus on generic medical device concepts rather than commercial terminology.
Step 1: Start with the intended purpose
The manufacturer’s intended purpose is a central part of the GMDN assessment.
Review the instructions for use, label, product description, technical documentation and relevant claims before searching.
Devices that appear physically similar can require different terms if their clinical purposes differ.
The intended purpose should also remain consistent with the South African classification and technical documentation.
Step 2: Search using generic device terminology
GMDN is a generic nomenclature rather than a database of commercial product names.
Search using the device type, clinical function, intended anatomical use, diagnostic target, technology or other generic descriptors.
If the results are too broad, refine the search using characteristics that distinguish the device from related products.
The objective is to identify the GMDN concept whose definition accurately covers the device.
Step 3: Read the full GMDN definition
Do not select a code based only on the GMDN Term Name.
Open the term and review the definition.
The definition may contain information relating to intended purpose, technology, sterility, reusability, clinical application and other characteristics.
A term that initially appears suitable may prove inappropriate once the full definition is considered.
Step 4: Compare similar terms
Where several GMDN terms appear suitable, compare their definitions carefully.
Consider whether the differences relate to sterility, clinical purpose, operating technology, reuse, self-testing, system configuration or another important product characteristic.
The selected term should be the one whose scope provides the most accurate fit for the device.
Step 5: Confirm that the GMDN term is active
GMDN is a dynamic nomenclature.
Terms can be introduced, amended or made obsolete as medical technologies and nomenclature structures evolve.
Before using a code obtained from an old registration, technical file or product spreadsheet, confirm its current status in the GMDN database.
Where a term has become obsolete, review the available alternative terms and determine which one accurately describes the product.
How should product variants be handled?
Several models or sizes may be covered by the same GMDN term where they share the characteristics described in the definition.
However, a product family’s variants should not automatically be assigned the same code merely because they share a commercial name.
Differences such as sterility, reuse, clinical purpose, operating technology or professional versus self-testing use may require a separate nomenclature assessment.
GMDN codes for accessories, systems and kits
Accessories and system components should be assessed according to the way they are actually placed on the market.
A separately supplied component should not automatically inherit the code of the main device.
Similarly, a system term should only be used where the supplied product genuinely fits the relevant system definition.
Review how the products are packaged, supplied and intended to function before determining the appropriate nomenclature.
Finding GMDN codes for IVDs
GMDN also applies to in vitro diagnostic medical devices.
For an IVD, relevant search characteristics can include the analyte, infectious agent, specimen, methodology, clinical purpose, professional or self-testing use and whether the product is a reagent, kit, instrument, control or calibrator.
SAHPRA’s 2024 registration feasibility study demonstrated this level of specificity by identifying eligible IVD products through detailed GMDN term names and codes.
The disease being tested is therefore not enough on its own to determine the appropriate IVD term.
What if no suitable GMDN term exists?
If no existing definition properly describes the device, the manufacturer should avoid forcing the product into an unrelated term.
The GMDN Agency provides mechanisms for users to raise enquiries concerning terminology and new or amended concepts.
Before doing so, search thoroughly and confirm that the apparent gap is not caused by brand terminology, an overly narrow search or misunderstanding of the device concept.
What happens when a GMDN code becomes obsolete?
An obsolete GMDN term is a nomenclature concept that has been retired.
This does not mean that the physical medical device automatically becomes invalid.
The licence holder should review the reason for obsoletion, identify appropriate alternative terms, update its controlled regulatory information and determine whether its South African product information should also be updated.
GMDN versus EMDN
GMDN and the European Medical Device Nomenclature, or EMDN, are different nomenclature systems.
As at October 2024, SAHPRA’s establishment licensing requirements specifically referred to GMDN codes.
An EMDN code used in a European regulatory system should therefore not simply be copied into the GMDN field of a South African application.
The applicable GMDN term should be identified independently.
GMDN codes in SAHPRA establishment licensing
GMDN information should be addressed before the product listing is finalised.
The product name, manufacturer, intended purpose, GMDN code and South African classification should all describe the same medical device consistently.
For the wider licensing process, see SAHPRA Medical Device Establishment Licence: Complete Guide.
Verion Medical also provides SAHPRA medical device establishment licensing support.
GMDN and South Africa’s developing registration framework
GMDN is also relevant to South Africa’s developing medical device registration system.
SAHPRA’s 2024 Medical Device Registration Voluntary Feasibility Study used GMDN categories and terms to identify product groups included in the project.
Manufacturers should therefore maintain accurate nomenclature information as part of broader registration readiness.
See Medical Device Registration in South Africa: SAHPRA Requirements.
Common GMDN coding mistakes
Common mistakes include searching only the commercial product name, selecting a code without reading its definition, copying a competitor’s code, assuming every product variant has the same term and confusing GMDN with SAHPRA risk classification.
Other errors include using obsolete codes, assigning the parent device’s term automatically to accessories, forcing innovative products into unsuitable terms and confusing GMDN with EMDN, UDI or internal catalogue numbers.
GMDN should be managed as controlled regulatory product information.
How to document a GMDN assessment
A useful GMDN assessment record should include:
- product name;
- model or family;
- manufacturer;
- intended purpose;
- brief device description;
- key nomenclature characteristics;
- search terminology;
- GMDN Term Name;
- GMDN Code;
- relevant GMDN Definition;
- term status;
- date verified;
- alternative terms considered where relevant; and
- a concise rationale for the selected term.
This provides an auditable rationale and makes future product-list maintenance easier.
Key regulatory and nomenclature references
- SAHPGL-MD-06, Guideline for a Licence to Manufacture, Import, Export or Distribute Medical Devices and IVDs
- SAHPGL-MD-07, Guideline on Questions and Answers: Licensing of Medical Device Establishments
- SAHPRA Medical Device Registration Voluntary Feasibility Study documentation
- GMDN Agency
Related Verion Medical insights
- Medical Device Classification in South Africa: Classes A, B, C and D
- Medical Device Registration in South Africa: SAHPRA Requirements
- SAHPRA Medical Device Establishment Licence: Complete Guide
- Manufacturer, Distributor or Wholesaler? Choosing the Right SAHPRA Licence
- How Foreign Medical Device and IVD Manufacturers Can Enter the South African Market
- Medical Device Wholesale Licence in South Africa: SAHPRA Requirements
How Verion Medical supports GMDN and product-list reviews
Verion Medical supports medical device and IVD manufacturers, importers and licence holders with the regulatory information required to build accurate South African product listings.
Our medical device classification service can support the review of intended purpose, device characteristics, South African risk classification and associated nomenclature information.
Where GMDN review forms part of an establishment licence application, Verion Medical also provides SAHPRA establishment licensing support, including portfolio reviews and product-list preparation.
Our wider medical device regulatory affairs services and medical device registration support can assist manufacturers in maintaining consistent product data across classification, technical documentation, licensing and registration-readiness activities.
The objective is not simply to populate the GMDN column of an application form. It is to ensure that the nomenclature, intended purpose, device classification and product information describe the same device accurately.
If your organisation needs to identify or verify GMDN codes before submitting a SAHPRA licence application or preparing a South African product portfolio, contact Verion Medical for a regulatory product-list review.