Health Canada has announced their intention to transition to Global Medical Device Nomenclature from its current categorization of medical devices. The intent of this change is to improve the availability, access and quality of information for medical devices in Canada.
The Global Medical Device Nomenclature (GMDN) consists of a list of names to identify all medical device products and is used to provide health authorities, regulators, health care providers, manufacturers and others with a naming system that can be used to accurately exchange information on medical devices. The GMDN is recommended by the International Medical Device Regulators Forum (IMDRF) and is currently used by more than 70 national regulatory bodies.
Medical device manufacturers who possess active medical device licenses will be invited to determine a GMDN code for each device. In addition, as part of every medical device application and licence amendment, applicants will be asked to provide GMDN data as well. The current GMDN database includes over 23,000 active terms covering a wide range of technologies and is constantly growing.
As part of the transition to GMDN, medical device manufacturers will be encouraged to obtain GMDN membership. There is a cost to membership which varies on the type of business that is applying. For information about pricing and the GMDN Agency, please visit the association’s web site.
For more information about how this regulatory change impacts your products, please do not hesitate to contact Focal Point Research Inc. We are leading Canadian regulatory and Health Canada consultants for Medical Devices
Recent Comments