To manage the GMDN, a non-profit maintenance agency was required. Such products include those used in the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans. FAQ Answers to frequently asked questions.
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This page was last edited on 20 Julyat Each Membership criteria provides Users with a limited number of free Code Credits when they join. For certain membership types selected Codes are automatically added to the users ggmdn Terms' list for your future reference and the GMDN Agency monitors these and sends notifications if the status changes.
What is the GMDN? 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 gmrn having substantially similar generic features, can be identified.
How often are new GMDN terms issued? 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. The enquiry process is complex and can take several weeks to complete, so please give us plenty of time to consider your enquiry.
Global Medical Device Nomenclature - GMDN
Certain membership types are informed by email if a term in their 'My Terms' list is modified or made obsolete. Please refer to the regulation that applies to medical devices in your country of bmdn. Views Read Edit View history. The Agency is managed by a Board of Trustees and Policy Advisory Group which represent medical device Regulators, manufacturers and healthcare providers.
How long does it take to develop a GMDN term?
To manage the GMDN, a non-profit maintenance agency was required. When sending an enquiry, please include as much information about the product as possible.
Users can register for access, apply for term changes and pay on-line. The following is an example:. The arrangement will enhance the application gmen care to individual patients for medical device, patient risk and safety use cases.
Medical device experts from around the world manufacturers, healthcare authorities and regulators compiled the GMDN, based on the international standard ISO All client information contained in the GMDN Database is password protected and not available to any other manufacturer member.
This Agreement is consistent with the aims of both organisations to minimise duplication and coode support harmonisation.
GMDN National Registration | GMDN Code | MDSS is Your Authorized Representative
From Wikipedia, the free encyclopedia. If you can't gjdn a term that is appropriate for your product, you can request assistance from the GMDN Agency.
Furthermore this nomenclature should be provided, to the maximum possible extent free of charge, also to other stakeholders. Fees for membership are reviewed each year by our Board to minimise the costs to Users. The GMDN is used by regulators, healthcare vmdn 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.
This is a single-use device. As seen in this example: The GMDN is not yet specified for the UDI database system proposed in new European Regulations  intended to be used by manufacturers of medical devices who have their own UDIs unique device identifiers and traceability. The GMDN Database lists all the terms, which are currently available to name and describe medical devices, although new terms are regularly issued to cods with new medical devices innovations.
Classification systems Health standards. We have a free on-line enquiry service that will review your product and the relevant existing GMDN terms.
What if I can't find a term for my product?
Global Medical Device Nomenclature - Wikipedia
The cpde is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. The following objectives were agreed:.
A sterile, hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade not an exchangeable component used by the operator to manually cut or dissect tissue.