To manage the GMDN, a non-profit maintenance agency was required. Once selected, the GMDN Code is made available to the User and then used for regulatory listing or data exchange purposes. Medical device experts from around the world manufacturers, healthcare authorities and regulators compiled the GMDN, based on the international standard ISO The following is an example:. 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. 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. If users no longer want us to monitor a Term in the their ‘My Terms’ list, this can be moved to their ‘My Archive’ list.
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For certain membership types selected Codes are automatically added to the users ‘My Terms’ list for your future reference and the GMDN Agency monitors these and sends notifications if the status changes. The Enquiry process is complex and can take several weeks to complete, so please give us plenty of time to consider your enquiry.
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 lists all the terms, which are currently available clde name and describe medical devices, although new gmnd are regularly issued to cope with new medical devices innovations. We have a free on-line Enquiry service see Help menu that will review your product and the relevant existing GMDN terms. As seen in this example: The decisions are made by an international expert team, according to ISO The GMDN is used by regulators, healthcare providers and others for activities such as medical device recalls, adverse event reporting and postmarket surveillance and monitoring, as well as inventory control and other healthcare management functions.
The arrangement will enhance the application of care to individual patients for medical device, patient risk and safety core cases.
FAQ – GMDN Agency
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. If users no longer want us to monitor a Term in the their ‘My Terms’ list, this can be moved to their ‘My Archive’ list.
The following objectives were ocde.
It is envisaged that the use of the GMDN by all countries will support the harmonisation of the definition of a medical device worldwide. This work was requested by the inter-governmental body, the Global Harmonisation Task Force GHTF to help accelerate international medical device regulatory harmonization and convergence.
The GMDN term is in the form of a 5-digit numeric GMDN Code cross-referenced to a specific Term Name and Definition, with which all specific medical devices having substantially similar generic features, can be identified.
The Users function is restricted to users with a specific permission on their GMDN account and may also be restricted cove membership type – please contact us for more information. Certain membership types are informed by email if a term in their ‘My Terms’ list is modified or made obsolete.
Global Medical Device Nomenclature
The following coed an example:. 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. But please let us know if your need is urgent.
Classification systems Health standards.
This page was last edited on 20 Julyat Please go to the Services menu on the website for more information. Please contact us if you have any concerns. Certain membership 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 chose an alternative Term for their product.
Global Medical Device Nomenclature – Wikipedia
Coe improves communication within the health-sector and helps Codee better understand information about medical device use. How often are new GMDN terms issued? If you can’t find a term that is appropriate for your product, you can request assistance from the GMDN Agency. Terms and Definitions are translated into many languages and your preference can be chosen from the main menu. The Agency is managed by a Board of Trustees and Policy Advisory Group which represent medical device Regulators, manufacturers and healthcare providers.
Medical device experts from around the world manufacturers, healthcare authorities and regulators compiled the GMDN, based on the international standard ISO This Agreement is consistent with the aims of both organisations to minimise duplication and to support harmonisation.