Nirg 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. How to obtain CE Marking for my product? Wellkang registers your products Class I Medical Devices gmdn code list the appropriate authorities.
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GMDN - the standard for naming and grouping medical devices. Your browser does not support the video tag. Such products include those used in the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans. 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 be used to exchange medical device information and support patient safety.
The GMDN is used for: Data exchange between manufacturers, regulators and healthcare authorities Exchange of post-market vigilance information Supporting inventory control in hospitals Purchasing and supply chain management Information in the form of a 5 digit numeric GMDN Code is cross-referenced to a precisely defined Term Name and Definition, as seen in this example: GMDN Term Name: Scalpel, single-use GMDN Code: GMDN Definition: 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 blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device. Users can register for access, apply for term changes and pay on-line.
For more information see Membership. How does it work? What could be simpler than that!
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