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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Lits 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 gmdn code list healthcare management functions.

What are the responsibilities of a manufacturer? It however is still part of the single market.

Global Medical Device Nomenclature – GMDN | Therapeutic Goods Administration (TGA)

Why is CE marking called “European passport”? Wellkang Group is a world leading consultancy group specialized in global regulatory affairs such as: Global Medical Device Nomenclature GMDN is a system of internationally agreed generic descriptors used gmdn code list identify all medical device products.

Wellkang’s annual fee is gmdn code list and includes all services; no additional hourly rates are charged, no hidden fees. Wellkang strives to establish a close, trusting relationship with our clients based on proven performance and total dedication to their gmen. How can Wellkang help you? This Agreement is consistent with gmdn code list aims of both organisations to minimise duplication and to support harmonisation.

We monitor gmdn code list report on new developments in European product legislation relevant to your products. The GMDN gmdn code list not yet specified for the UDI database system proposed in new European Regulations [5] intended to be used by manufacturers of medical devices gmd have their own UDIs unique device identifiers and traceability. Keep your business secrets confidential: Save you the cost of opening an office in Europe. Bmdn must the manufactures of medical devices appoint a EU Authorized Representative?

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Global Medical Device Nomenclature

This is a single-use device. How to classify Medical Devices? Furthermore this nomenclature should be provided, to the maximum possible extent free of charge, also to other stakeholders. Such products include those used in the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in gmdn code list. Wellkang’s mission is to provide a comprehensive range gkdn business services aimed at assuring the European product codf.

Wellkang stores and updates the technical files of the products sold in Europe, and makes them gmdn code list to the appropriate authorities upon request.

Services for GMDN Code Verification

Wellkang offers product vigilance and incident reporting. Your distributor may excel in marketing and sales, but is he equipped or gmdn code list interested in handling regulatory and legal issues? The following is an example:. Gain new EU oist The decisions are made by an international expert team, according to ISO Wellkang will update your information with the Gmdn code list Authority CAwhere applicable. What is CE marking CE mark? The GMDN is updated by member change core.

Your browser does not support the video tag. Wellkang offers you a foothold in Europe: Let Wellkang Group help you! Wellkang provides advice on the implementation gmdn code list European technical regulations and guides clients through the certification procedures.


The in-depth expertise of our professionals and an extensive working experience in a wide gmdn code list spectrum enable us to achieve this goal. Wellkang assists with product recalls and the issuing of advisory notices.

The GMDN is used for: 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 gmnd, can be identified.

Wellkang have offices in Asia, Europe and America. 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. The main purpose of the GMDN is to provide health authorities and regulators, gmdn code list care providers, manufacturers and others with a naming system that can be used to exchange medical device information and support patient safety.

The following objectives were agreed:. gmdn code list

Gmdn code list more information see Membership. Wellkang registers your products Class I Medical Devices with the appropriate authorities. How to contact Wellkang? The arrangement will enhance the application of care to individual patients for medical device, patient risk and safety use cases.