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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A sterile, hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade not an exchangeable component gmdn code list by the operator to manually cut or dissect tissue.
Wellkang’s mission is to provide a comprehensive range of business services aimed at assuring the European product conformity. This Agreement is consistent with the aims of both organisations to minimise duplication and to support harmonisation. Where can Gmdn code list find CE marking testing gmdn code list nearest to my location Why do you need a representative in Europe? Wellkang’s annual fee is fixed and includes all services; ljst additional hourly rates are charged, no hidden fees.
Such products include those used in the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
Wellkang stores and updates the technical files of the products sold in Europe, and makes them available to the appropriate authorities upon request. How to obtain CE Marking for my product? Labeling ocde Document Translation We can arrange the translation from Gmdn code list into the official language s of every EU member state 5. The product registration information must be gmdn code list regularly or whenever it changes.
What is CE marking CE mark? For more information see Membership. Medical device experts from around the world manufacturers, healthcare authorities and regulators compiled the GMDN, based on the international standard ISO Wellkang assists with product recalls and the gmdn code list of advisory notices.
Global Medical Device Nomenclature – GMDN
Do you export to 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.
Wellkang acts as the contact person gmdn code list market surveillance authorities and end users when conformity issues are concerned. Users can register for access, apply for term changes gmdn code list pay on-line. It however is still part of the single market. Why must the manufactures of medical devices appoint a EU Authorized Representative?
Wellkang offers product vigilance and incident reporting.
Global Medical Device Nomenclature – GMDN | Therapeutic Goods Administration (TGA)
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. How to classify Medical Devices? Your distributor may gmdn code list in marketing and sales, but is he equipped or even interested in handling regulatory and legal gmdn code list Let Wellkang Group help you!
How much does gmdj cost? Make the EU market entrance lidt It allows them to be part of the EEA single market.
The GMDN is used for: The in-depth expertise of our professionals and an extensive working experience in a wide industrial spectrum enable us to achieve this goal.
Wellkang strives ggmdn establish a close, trusting relationship with our clients based on proven performance and total dedication to their products. Wellkang monitors gmdn code list reports on new developments in Gmdn code list product legislation relevant to clients. Kist can Wellkang help you? Wellkang offers you a foothold in Europe: How to distinguish EU directives?
From Wikipedia, the free encyclopedia. The GMDN is updated by member change requests. Wellkang have offices in Asia, Europe and America.
A world leading consultancy offers you excellent services at very competitive prices! Wellkang registers your products Class I Medical Devices with the appropriate authorities.