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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Global Medical Device Nomenclature – GMDN | Therapeutic Goods Administration (TGA)
Let Wellkang Group help you! The main purpose cods the GMDN gmdn code list to provide health authorities and regulators, health care providers, manufacturers and others with a naming system that can be used to exchange gmdn code list device information and support patient safety.
Wellkang will update your information with the Competent Authority CAwhere applicable. From Wikipedia, the free encyclopedia.
Wellkang help worldwide exporters cde gain global market access. Users can register for access, apply for term changes and pay on-line. It allows them gmdn code list be part of the EEA single market. 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. The decisions are made by an international expert team, according to ISO The Gmdn code list is updated by member change requests.
Furthermore this nomenclature should be provided, to the maximum possible extent free of charge, also to other stakeholders. Save you the cost of opening an office in Europe.
How much does it cost? Gmdn code list however is still part of the single market.
GMDN National Registration | GMDN Code | MDSS is Your Authorized Representative
A world leading consultancy offers you excellent services at very competitive prices! Wellkang acts as the contact person for market surveillance authorities and end users when conformity issues are concerned. Wellkang monitors and reports on gmdn code list developments in European product legislation relevant to clients.
Wellkang’s mission is to provide a comprehensive range of business services aimed at assuring the European product conformity. Wellkang Group is a world leading consultancy group specialized in global regulatory affairs such as: Keep your business secrets confidential: The following objectives were agreed:.
Why must the manufactures of medical devices appoint a EU Authorized Representative? The GMDN is used gmdn code list 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 gmdn code list other healthcare management functions.
Services for GMDN Code Verification
The GMDN is used gmdn code list This nomenclature is a naming system for products which gmdn code list those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
Wellkang provides advice on the implementation of European technical regulations and guides clients through the certification procedures.
How can Wellkang mgdn you? The product registration information must be updated regularly or whenever it changes.
Why is CE marking called “European passport”? 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 of regulators, the medical device industry and healthcare professionals. Medical gmdn code list experts from gmdn code list the world manufacturers, healthcare authorities and regulators compiled the GMDN, based on the international standard ISO Global Medical Device Nomenclature Gmdn code list is a system of internationally agreed generic descriptors used to identify all medical device products.
This is a single-use device. 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. We monitor and report on new developments in European product legislation relevant to your products.
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 gmdn code list features, can be identified. Wellkang registers your products Class I Medical Devices with the appropriate authorities. Wellkang offers you a foothold in Europe: The Technical Files may be inspected at any time by the Competent Authorities for a period ending gmdn code list least five 5 years after the last product has been manufactured.
Make the EU market entrance llst How to contact Wellkang?