The Global Medical Device Nomenclature (GMDN) is a list of generic names Information in the form of a 5 digit numeric GMDN Code is cross-referenced to a. GMDN codes and terms allow medical devices with similar features to be identified and are used by the TGA to assist in. Pack / Device -. Unique Device Identifier. (e.g. ). Hudson. Generic Device Group -. GMDN Term. (e.g. GMDN Code ).

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The arrangement will enhance the application of care to individual patients for medical device, patient risk and safety use cases. How to distinguish EU directives?

Global Medical Device Nomenclature – Wikipedia

Labeling and Document Translation We can arrange the translation from English into the official language s of every EU member state 5. Why gmdn code list CE marking called “European passport”? The blade is typically made of high-grade stainless steel alloy or cpde steel and the handle is often made of plastic. This page was last edited on 20 Julyat Where can I find CE marking testing labs nearest to my location Why do you need a representative in Europe?

This Agreement is consistent with the aims of both organisations to minimise duplication and to support harmonisation. The GMDN is used for: Wellkang provides advice on gmdn code list implementation of European technical regulations and guides clients through the certification procedures. How can Wellkang help you?

The main purpose of the GMDN is to provide health authorities and regulators, health care providers, manufacturers and others with a naming system that can cods used to exchange medical device information and support patient safety. For more information see Membership. Wellkang acts as the contact person for market surveillance authorities and end users when conformity issues are concerned. Views Read Edit Gmdn code list history. gmdn code list


Do you export lisst Europe? Wellkang have offices in Asia, Europe and America. Medical device experts from around the world manufacturers, gmdn code list authorities and regulators compiled the GMDN, based on the international standard ISO Global Medical Device Nomenclature GMDN is a system of internationally agreed generic descriptors used to identify gmdn code list medical device products. 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 Agreement will benefit patients across the world gmdn code list all users of SNOMED CT and the GMDN in promoting comprehensive terminology based medical records, covering the needs of regulators, the medical device industry and healthcare professionals. Such products include those used in the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.

Make the EU market entrance simple: Gkdn Wellkang Group part of the U.

Services for GMDN Code Verification | OBELIS MEDICAL DEVICES

Data exchange between manufacturers, regulators and gmdn code list authorities Exchange of post-market vigilance information Supporting inventory control in hospitals Purchasing and supply chain management The GMDN is recommended by the International Medical Device Regulators Forum IMDRF and is now used by over 70 national medical device regulators to support their gmdn code list.

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.


This nomenclature is a lust system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans. The Technical Files may be inspected at any time by the Competent Authorities for a period gmdn code list at least five 5 years after the last product has been manufactured.

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 gdn substantially similar generic features, can be identified. Furthermore gmdn code list nomenclature should be provided, to the maximum possible extent free of charge, also to other stakeholders.

Global Medical Device Nomenclature – GMDN

From Wikipedia, the free encyclopedia. The GMDN is updated by member change requests. Oist annual fee is fixed and includes all services; no additional hourly rates are charged, no hidden fees.

Gain new EU market: It allows them to be part of the EEA single market. Wellkang strives to establish a close, trusting gmdn code list with our clients based gjdn proven performance and total dedication to their products. The decisions are made by an international expert gmdn code list, according to ISO Users can register for access, apply for term changes and pay on-line.