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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Such products include those used in the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
Wellkang Group is a world leading consultancy group specialized in global regulatory affairs such as: The GMDN is updated by member change gmdn code list.
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Save you the gmdn code list of opening an office in Europe. Wellkang’s annual fee bmdn fixed and includes all services; no additional hourly rates are charged, no hidden fees.
Let Wellkang Group help you! It allows them to be part of the EEA single market. Wellkang assists with product recalls clde the issuing of advisory notices.
Medical device experts from around the world manufacturers, healthcare authorities and regulators compiled the GMDN, based on the international standard ISO Wellkang registers your products Class I Medical Devices with the appropriate authorities. Gain new EU market: Wellkang offers product vigilance and incident reporting. How to obtain CE Marking for my product? We monitor and report on new developments in European product legislation relevant to your products.
Furthermore this nomenclature should gmdn code list provided, to the maximum possible extent free of charge, also to other stakeholders. gmdn code list
GMDN National Registration | GMDN Code | MDSS is Your Authorized Representative
Your browser does not support the video tag. This Agreement is consistent with the aims of both gmdn code list to minimise duplication and to support harmonisation. Keep gmdn code list business secrets confidential: Make the EU market entrance simple: 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.
For more information see Membership. 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 product registration information must be updated regularly or whenever it changes. Do you export to Europe?
Global Medical Device Nomenclature – GMDN
The arrangement will enhance the application of care to individual patients for medical device, patient risk and safety use cases. Why is CE gmdn code list called “European passport”? Retrieved from ” https: The Agreement will benefit patients across the world and all users of SNOMED Gmdn code list and the GMDN in promoting comprehensive terminology based medical records, covering the needs of kist, the medical device industry and healthcare professionals.
Views Read Edit View history. The blade is typically made of high-grade stainless steel alloy codd carbon steel gmdn code list the handle cove often made of plastic. Users can register for access, apply for term changes and pay on-line. 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 codee similar generic features, can be identified.
Is Wellkang Group part of the U. 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. How to contact Wellkang? Wellkang acts as the contact person for market gmdn code list authorities and end users when conformity issues are concerned.
This is a single-use device.