Health Canada is initiating the transition from their current medical device categorisation method to the Global Medical Device Nomenclature (GMDN). The aim is to improve the availability, accessibility and the quality of information available on medical devices in Canada. Health Canada states that they will provide manufacturers with a list of their medical devices associated with active medical device licences.
The GMDN is a list of generic names that are used to identify all medical devices and allow easier exchange of information, including post-market and supply chain data, between health authorities and regulators, healthcare providers and manufacturers. The International Medical Device Regulators Forum (IMDRF) recommends the use of the GMDN and the agency states that the system is now used by over 70 national device regulators. The GMDN database currently includes over 23,000 active terms covering all major technologies and intended uses, and is in continual evolution.
Health Canada is updating the medical device licence application and licence amendment forms, and manufacturers will be invited to determine the GMDN code for each device. Once the forms are available, applicants will be asked to provide the GMDN data as part of all new applications and licence amendment applications. “Codes received from manufacturers will be subjected to review prior to being added to the internal database. In case of codes found to be incorrect, Health Canada may contact the manufacturer for clarification.” Health Canada states that this will not delay the processing of applications and a screening deficiency will not be issued.
To read more about Health Canada’s transition to the GMDN, please click here.