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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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What are the responsibilities of a manufacturer? Medical device experts gmdn code list around the world manufacturers, healthcare authorities and regulators compiled the GMDN, based on the international standard ISO The decisions are made by an international expert team, according to ISO Global Medical Device Nomenclature GMDN is a system of internationally agreed generic descriptors used to identify all medical device products.
For more information see Membership.
Global Medical Device Nomenclature – GMDN
The following is an example:. How to obtain CE Marking for my product? Wellkang registers your products Class I Medical Devices gmdn code list the appropriate authorities. Wellkang offers you a foothold in Europe: This nomenclature is a gmdn code list system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or lisst in humans.
From Wikipedia, the free encyclopedia. Users can register for access, apply for term changes and pay on-line.
Global Medical Device Nomenclature – Wikipedia
Where can I find CE marking testing labs nearest to my location Why do you need a representative gmdn code list Europe? Data exchange between manufacturers, regulators and healthcare 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 activity.
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 who have their own UDIs unique device identifiers and traceability. Wellkang acts as the contact person for market gmdn code list authorities and end users when conformity issues are concerned.
GMDN National Registration | GMDN Code | MDSS is Your Authorized Representative
This page was last edited on 20 Julyat What is CE marking CE mark? Wellkang will update your information gmdn code list the Competent Authority CAwhere applicable.
The in-depth expertise of our professionals and an extensive working experience in a wide industrial spectrum enable us to achieve this goal.
Wellkang’s mission is gmsn provide a comprehensive range of business services aimed at assuring gmdn code list European product conformity.
Gmdn code list your gmdn code list secrets confidential: Labeling and Document Translation We can arrange the translation from English into the official language s of every EU member state 5.
It however is still part of the single market. 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.
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Global Medical Device Nomenclature
Why is CE marking called “European passport”? The GMDN term is in the form of a 5-digit numeric GMDN Code gmdn code list to gmddn specific Term Name and Definition, with which all specific medical devices having substantially similar generic features, can be identified.
Wellkang strives to establish gmdn code list close, trusting relationship with our clients based on proven performance and total dedication to their products.
How to gmmdn Medical Devices? How much does it cost? The following objectives were agreed:. Is Gmdn code list Group part of the U. How to distinguish EU directives? Views Read Edit View history.
The arrangement will enhance the application of care to individual patients for medical device, patient risk and safety use cases. The GMDN is used for: Wellkang have offices in Asia, Europe and America.
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Gain new EU market: Gmdn code list allows them to be part of the EEA single market. Wellkang provides advice on the implementation of European gmdj regulations and guides clients through the certification procedures. Wellkang offers product vigilance and incident reporting.