Health Canada announced that it is initiating a transition from its current medical device categorization method to the Global Medical Device Nomenclature (GMDN), as part of a push to improve the availability, access to and quality of information available on medical devices in Canada.
Later this month, Health Canada says it will provide manufacturers with a list of their medical devices associated with active medical device licenses.
“Manufacturers will be invited to determine the GMDN code for each device. Health Canada is also updating the medical device licence application and licence amendment forms,” the regulator said in a notice. “Once these 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. This will not delay the processing of applications. A screening deficiency will not be issued.”
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The nomenclature is a list of generic names used to identify all medical devices and allow the easier exchange of information, including post-market and supply chain data, between health authorities and regulators, health care providers, manufacturers and others, according to the GMDN agency, a registered charity with a Board of Trustees representing regulators and industry that manages the system.
The International Medical Device Regulators Forum (IMDRF) also recommends the use of the GMDN and the agency said the system is now used by over 70 national device regulators. According to Health Canada, the GMDN database currently includes over 23,000 active terms covering all major technologies and intended uses and is in constant evolution.
Health Canada also encouraged manufacturers to obtain a GMDN membership. “Health Canada is aware that there is a cost for manufacturers to gain membership and therefore will provide support in identifying the GMDN codes to those who are unable to,” the notice said.
