GMDN CODE LIST PDF

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 ).

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Information is outdated or wrong. Finally, of course, there is the myriad of users, who, when the devices initially arrive at the place of intended use, struggle with an important task of correctly identifying and registering these devices in their local databases.

Codes in the range of 1 — Internationally, it provides a common terminology, enabling global regulatory partners to efficiently communicate and share medical device details. The preferred term type identifier is P. This is why the ccode of GMDN in a UDI system appears to many regional regulatory authorities and to the industry at large, as an effective tool to protect public health more efficiently.

Global Medical Device Nomenclature. The aim of the project was to create a comprehensive nomenclature for all medical devices, suitable for use by all interested parties globally. Lizt all regulations concerned with medical devices, there are a number of obligations placed upon the manufacturer.

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Global Medical Device Nomenclature – Wikipedia

To coordinate and link with appropriate organizations for the translation of GMDN into other languages. To be responsible for adding, amending, and archiving terms and definitions for medical devices and to assign codes as required, to provide easy identification. Code Code 01 Active implantable devices 02 Anesthetic and respiratory devices 03 Dental devices 04 Electromechanical medical devices 05 Hospital hardware 06 In vitro diagnostic devices 07 Non-active implantable devices 08 Ophthalmic and optical devices 09 Reusable devices 10 Single use devices 11 Assistive products for persons with disability 12 Diagnostic and therapeutic radiation devices 13 Complementary therapy devices 14 Biological-derived devices 15 Healthcare facility products and adaptations 16 Laboratory equipment 17 Reserved 18 Reserved 19 Reserved 20 Reserved.

Questions or concerns regarding this notice should be directed to: The codes are the carriers of the information to which they are linked and should always be used and referred to in any reference to the GMDN or data transaction. Template terms 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.

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The generic device group is the most specific level at which products are aggregated, based on common technology or intended use.

Global Medical Device Nomenclature

Open in a separate window. The synonym oist is a navigational tool only and must not be used for product identification purposes. 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.

Finally, the current area of focus and vision for the future are also mentioned. There are fees associated with membership, though reduced fees are available for ccode manufacturers which are those who have less than 1 million euros in annual sales. By lixt 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.

Health Canada is aware that there is a cost for manufacturers to gain membership gmmdn therefore will provide support in identifying the GMDN codes to those who are unable to. The template term is a navigational tool only and gmdh not be used for product identification purposes. In lost to accommodate most methods of labeling, marking, and identifying products, the UDI should be technology neutral, that is, it should not be restricted to a particular method of Automatic Identification and Data Capture AIDC.

Although the GMDN has been designed and developed for regulatory data exchange in areas such as vigilance reporting and tracking of medical device safety, there is a need ocde a set of terms that are more refined than the GMDN category terms, yet broader than the GMDN generic device group terms, to be used in the application of the medical device directives; the use of collective terms satisfies this requirement.

This will not delay the processing of applications. Finally, in order to achieve all the positive elements of a UDI mechanism, the use of the UDI should be promoted among all stakeholders, including regulatory agencies, medical device manufacturers, distributors, lisy, and medical professionals. To liaise with standards bodies e. There are four different types of GMDN terms associated with the generic device groups. Using the GMDN search engine, or using some of the view possibilities provided by the database, E terms can be found and viewed.

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Views Read Edit View history. From Wikipedia, the free encyclopedia. This means that there are a number of players, having quite different responsibilities and levels of understanding of the processes, but all with one common interest, that of ensuring the availability of sound medical devices to the general public. 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.

Once these forms are available, applicants will be asked to provide the GMDN data as part of all new applications and licence amendment applications. Login error when trying to access an account e.

Services for GMDN Code Verification | OBELIS MEDICAL DEVICES

To ensure that the GMDN meets the needs of all national authorities, the industry, and other users globally, as the primary reference and working generic nomenclature for the exchange of regulatory and commercial information. Utilization of GMDN clde unique device identification For the gmnd of patient safety, in the era of global economy, it is desirable to address tracking and tracing of medical devices lust a global level. This page was last edited on 20 Julyat Furthermore this nomenclature should be provided, to the maximum possible extent free of charge, also to other stakeholders.

Cde Service Canada Account. The following is an example:. Retrieved from ” https: The codes in themselves are not created with an integral hierarchical structure and are simply unique numbers. It will also improve the work of market surveillance authorities in case of field safety corrective actions, for instance, the fight against counterfeiting. The GMDN Agency has therefore exercised, and will continue to exercise, the sole rights to develop and distribute all versions of the GMDN and its associated data, terminology, and supporting databases.