GMDN codes and terms allow medical devices with similar features to be identified and are used by the TGA to assist in. Brief Summary: The 12 categories in the GMDN (Global Medical Device Nomenclature) Code table are: Code Term 01 Active implantable. Pack / Device -. Unique Device Identifier. (e.g. ). Hudson. Generic Device Group -. GMDN Term. (e.g. GMDN Code ).

Author: Tonris Tojagar
Country: Kuwait
Language: English (Spanish)
Genre: Business
Published (Last): 6 January 2004
Pages: 483
PDF File Size: 11.3 Mb
ePub File Size: 18.66 Mb
ISBN: 584-7-40835-445-6
Downloads: 43303
Price: Free* [*Free Regsitration Required]
Uploader: Shakaramar

The template term is a general device name added to the nomenclature when multiple preferred terms have identical character strings forming a base concept, and functions as a header term to create a simple hierarchy for lexically-related preferred terms.

Services for GMDN Code Verification

All terms in the GMDN are assigned a unique code. To coordinate and link with appropriate organizations for the translation of GMDN into other languages. JYP are provided here courtesy of Elsevier. Therefore, in order to manage the GMDN, a maintenance agency was set up to form the necessary legal entity. Classification systems Health standards. Physeon Enrolls First Patient in U.

This multiple-linked synonym term is a navigational tool only and must not be used for product identification purposes. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media. Codes in the range of 1 — are not represented in the GMDN. This will lead to ambiguity.

The GMDN is not yet specified for the UDI database system proposed in new European Regulations [5] intended to be used by manufacturers of medical devices who have their own UDIs unique device identifiers and traceability. Login error when trying to access an account e.

Currently, the GMDN terms cover mostly medical devices.

Global Medical Device Nomenclature – Wikipedia

This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans. Furthermore this nomenclature should be provided, to cpde maximum possible extent free of charge, also to other stakeholders. It divides the entire medical device product market into the highest-level groups based on device application, technology, or other common characteristics.


Author information Copyright and License information Disclaimer. A link, button or video is not working. Health Canada is initiating the transition from its current medical device categorization method to the Global Medical Device Nomenclature GMDNin order to improve the availability, access to, and the quality of information available on medical devices in Canada.

There were several means identified to aggregate the generic device group terms of the GMDN using collective terms. 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 gmdm substantially similar generic features, can be identified.

Potential for a system of unique device identification that links device-group information with device-type information. The advent of the European directives, initiated a new era, where national and indeed international bodies were given the opportunity to cooperate and harmonize their efforts in achieving the one thing that they all needed, tmdn, a standardized method of identifying the products placed in the global market.

Notice: Improving access to medical devices information –

My Service Canada Account. These terms, with their alpha identifiers, include the: From Wikipedia, the free encyclopedia.

Continuous and significant technological advancement in the field of medical devices makes it necessary for Health Canada to implement a nomenclature designed to keep pace with medical devices innovations. Wounds covered by e-bandages closed within 3 days, compared with 12 days for a control bandage.

There are lis different types of GMDN terms associated with the generic device groups. There are only three categories of ranges that are used in the coding system for GMDN.

Other issue not in this list. GMDN codes and terms are used internationally, and industry officials hope that the GMDN will become the nomenclature scheme adopted by countries worldwide.

It also provided services and information for access to the GMDN data through gmdnn Internet site or other means.

In addition, the development of an international approach will make the trade of medical devices more secure for all the stakeholders health authorities, hospitals, manufacturers, distributors, etc. In addition, the authorities are faced with the task of regulating the manufacturers and their devices, and there are the people involved in the trade of these devices e. Prior to the GMDN, many nomenclature systems existed, all built upon different structures, and gmn locally or nationally for diverse purposes and with unusual liist.


Footnotes Source of Support: Continue to prepare for harmonized regulatory cde of GMDN by developing requirements for the integration of GMDN data into device registration as well as approval applications.

Notice: Improving access to medical devices information

The decisions are made by an international expert team, according to ISO The GMDN database currently includes over 23 active terms covering all major technologies and intended uses, and is in constant evolution. To summarize, we can say that after adopting the GMDN concept there may be, Common terminology for efficient data lsit and communication.

To be used to identify the range of skills and general technological abilities for which a Notified Body has been approved, and is so appointed by the relevant Competent Authority.

Global medical device nomenclature structure The general structure of the GMDN is regulated by requirements stipulated in the standard ISO Nomenclature — Medical device nomenclature data structure. Selecting a synonym term in the GMDN database will automatically produce its linked preferred or template term. Collective terms Collective terms are used to aggregate medical device groups that have common features and are identified in the GMDN.

In future a high-quality medical device terminology gmdnn be the standard that promotes good data management, which should be associated with unique device identification[ 4 ]. Specifically, their utilization by regulators will help to improve nomenclature practices, cross-generational consistency, and data management, for post-market activities. It defined the general structure of the nomenclature and provided lsit required understanding of field lengths, data relationships, and ocde on.

It will also improve the work of market surveillance authorities in case of field safety coxe actions, for instance, the fight against counterfeiting. Nil Conflict of Interest: By adopting the GMDN, Health Canada will be in a better position to fulfill its mission to help Canadians maintain and improve their health, since better quality information will be available to Canadian health authorities, health care providers, manufacturers, and Canadians.

To liaise with standards bodies e.