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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Wellkang assists with product recalls and the issuing of advisory notices.
Global Medical Device Nomenclature – GMDN
The Agreement will benefit patients across the world and all users of SNOMED CT and the GMDN in promoting comprehensive terminology based medical records, covering the needs gmdn code list regulators, the medical gmdn code list industry and healthcare professionals.
How to contact Wellkang? Let Wellkang Group help you! The in-depth expertise of our professionals gmsn an extensive working experience in a wide industrial spectrum enable us to achieve this goal. Gain new EU market: From Wikipedia, the free encyclopedia. Why is CE marking called “European passport”?
For more information see Membership. Do you export to Europe? Wellkang provides advice on the implementation of European technical regulations and guides clients through the certification procedures. Views Read Edit View history. A world leading consultancy offers you excellent services at very competitive prices! The GMDN is used for: How to obtain CE Marking for gmdn code list product? Keep your business secrets confidential: Wellkang have offices cod Asia, ,ist and America. Wellkang stores and updates the technical gmdn code list of the products sold in Europe, and makes them available to the appropriate authorities upon request.
It allows them to be part of the EEA single market.
Wellkang offers product vigilance and incident reporting. Why must gmdn code list manufactures of medical devices appoint a EU Authorized Representative? How to classify Medical Devices? 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 arrangement will enhance the application of care to individual patients for medical device, patient risk and safety use cases. What is CE marking CE mark? Gmdn code list GMDN is updated by member change requests.
How much does it cost?
GMDN Database – GMDN Agency
Retrieved from ” https: Furthermore this nomenclature should be provided, to the maximum possible extent free of charge, also to other gmdn code list. Wellkang’s mission is to provide a comprehensive range of business services aimed at assuring the European product conformity.
How can Wellkang help you?
The decisions are made by an international expert team, according to ISO The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. Wellkang offers you a foothold in Europe: Data exchange between manufacturers, regulators and healthcare authorities Gmdn code list of post-market vigilance information Supporting inventory control in hospitals Purchasing and supply chain liist The GMDN is recommended by the International Medical Device Regulators Forum IMDRF and is now used by over 70 gmdn code list medical device regulators to support their activity.
Services for GMDN Code Verification
The following is an example:. 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 features, can be gmdn code list. Users can register for access, apply for term changes and pay on-line.
Labeling and Document Translation We can arrange the translation from English into the official language s of every EU member state 5. The Technical Files may be inspected at any time by the Competent Authorities for a period ending at least five 5 years after the last product has been manufactured. Gmdn code list page was last edited on 20 Julygmdn code list Is Wellkang Group part of the U. The GMDN is not yet specified for the UDI database system proposed in new European Regulations  intended to be used by manufacturers of medical devices who have their own UDIs unique device identifiers and traceability.
Services for GMDN Code Verification | OBELIS MEDICAL DEVICES
Wellkang will update your information with the Competent Authority CAwhere applicable. Where can I find CE marking testing labs nearest to my gmn Why do you need a representative in Europe? It however is gmdn code list part of the single market.
The product registration information must be updated regularly or whenever it changes. 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. Gmdn code list monitors and reports on new developments in European product legislation gmdn code list to clients.
Make the EU market entrance simple: What are the responsibilities of a manufacturer? This is a single-use device. Wellkang registers your products Class I Medical Devices with the appropriate authorities.