FAQ

What is the GMDN?
How can I get a GMDN Code for my product?
Do I register my product with the GMDN Agency?
Do all manufacturers need to find GMDN Codes for their products?
What is the difference between a GMDN Term and a GMDN Code?
How often are new GMDN terms issued?
What if my GMDN term is modified by the GMDN Agency?
What if I can't find a term for my product?
What if I urgently need to register my product and can't find a suitable GMDN Code?
Can anyone see the GMDN Codes I have chosen?
Can I see all the GMDN Codes?
What if I want to share the GMDN access across my organisation?
What if I choose the wrong GMDN Code?
Is the GMDN available in other languages?
How long does it take to develop a GMDN term?
When a GMDN term is modified or made obsolete will I have to reallocate the UDI on my product and re-label?
If a product has a GMDN Code is it a Medical Device?


Question

What is the GMDN?

Answer

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 managed by the GMDN Agency.

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Question

How can I get a GMDN Code for my product?

Answer

Only GMDN Membership can give you access to the GMDN Codes. The GMDN Agency is a registered charity. The Agency is managed by a Board of Trustees and Policy Advisory Group which represent medical device Regulators, manufacturers and healthcare providers. Fees for membership are reviewed each year by our Board to minimise the costs to Users. After joining the GMDN Terms and Codes are found on our website using a simple search tool. Please go to the Membership menu on the website for more information.

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Question

Do I register my product with the GMDN Agency?

Answer

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

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Question

Do all manufacturers need to find GMDN Codes for their products?

Answer

Medical Device Regulators may specify the use of the GMDN to their specific country or region. For example, regulators in the European Economic Area (EEA), request the use of GMDN to support the Conformity Assessment process required for CE marking. In the USA the FDA have introduced the use of the GMDN as part of their UDI Rule. The medical device Regulators in 65 countries are using the GMDN to support patient safety and beginning to require the use of the GMDN Code in their medical device listing / approval process.

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Question

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

Answer

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 users can search all the Term Names and Definitions for the most appropriate description of their product. Once selected, the GMDN Code is made available to the User and then used for regulatory or data exchange purposes. Selected Codes are automatically added to the users 'My Terms' list for future reference and tracking.

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Question

How often are new GMDN terms issued?

Answer

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

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Question

What if my GMDN term is modified by the GMDN Agency?

Answer

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 product group. Registered Members with these particular Terms in their 'My Terms' list will be notified automatically by email, so that they can consider whether or not to chose an alternative Term for their product.

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Question

What if I can't find a term for my product?

Answer

If you can't find a term that is appropriate for your product, you can request assistance from the GMDN Agency. We have an 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 justified or an existing term may need to be modified or an existing term maybe 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.

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Question

What if I urgently need to register my product and can't find a suitable GMDN Code?

Answer

Regulators and CABs know the process for new term requests used by the GMDN Agency and accept a delay in providing a GMDN Code, provided an application for a new term has already been made.

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Question

Can anyone see the GMDN Codes I have chosen?

Answer

All client information contained in the GMDN Database is password protected and not available to any other manufacturer 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.

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Question

Can I see all the GMDN Codes?

Answer

The GMDN Codes are protected so that Users can only see codes relevant to their product range. This is done by the User searching the GMDN database until they find the most appropriate GMDN Term for their product. Users can see all 22,000+ GMDN Terms in the database. The User can then use a Code Credit to reveal the related GMDN Code (this is a 5-digit number). The GMDN Term is then automatically added to the Users 'My Terms' list, for future reference. Each Membership criteria provides Users with a limited number of free Code Credits, although additional Code Packs can be purchased at any time.

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Question

What if I want to share the GMDN access across my organisation?

Answer

Multi-user access is managed within the GMDN database by the 'My User' function, found in 'My GMDN' menu. Multi-site access is managed with an additional Group Membership Licence Agreement - please contact us for more information.

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Question

What if I choose the wrong GMDN Code?

Answer

If the User wishes to change the GMDN Code selected for a particular product, it is recommended that the User discusses this with their Regulator or Conformity Assessment Body. Please contact us if you have any concerns.

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Question

Is the GMDN available in other languages?

Answer

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. The GMDN Agency with the support of Regulators has appointed translators for this special task. The GMDN Database provides translators with a range of facilities, to manage terminology, link the different language versions of the GMDN and support quality control.

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Question

How long does it take to develop a GMDN term?

Answer

There are several aspects to term development: 1) Request assessment and assignment – about 4 – 7 days; 2) Additional information gathering - depends on timeliness of manufacturer’s response; 3) Processing and quality control - 7 – 10 days depending on complexity of existing terms in the device area; 4) Requestor approval - depends on timeliness of manufacturer’s response; 5) Finalising term - 1 day (the 14 day public review period may be selected by some manufacturers).

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Question

When a GMDN term is modified or made obsolete will I have to reallocate the UDI on my product and re-label?

Answer

GMDN code is 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 relabeling that would result. As part of their implementmentation 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.

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Question

If a product has a GMDN Code is it a Medical Device?

Answer

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.

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