Notice: Improving access to medical devices information
May 22, 2018
Our reference number: 18-104326-657
Health Canada is adopting the Global Medical Device Nomenclature (GMDN)
Health Canada is initiating the transition from its current medical device categorization method to the Global Medical Device Nomenclature (GMDN), in order to improve the availability, access to, and the quality of information available on medical devices in Canada. Continuous and significant technological advancement in the field of medical devices makes it necessary for Health Canada to implement a nomenclature designed to keep pace with medical devices innovations.
Health Canada's decision to use the GMDN is in line with the recommendation of the International Medical Device Regulators Forum (IMDRF) and supports the Federal Government's Open Government initiative by improving the quality of medical devices data available to the public and leading to greater transparency.
The GMDN is an identification tool used worldwide by several medical device regulators. It is a list of generic names used to identify medical device products, allowing for efficient and timely information exchange between jurisdictions and effective monitoring by regulators. The GMDN database currently includes over 23 000 active terms covering all major technologies and intended uses, and is in constant evolution.
By adopting the GMDN, Health Canada will be in a better position to fulfill its mission to help Canadians maintain and improve their health, since better quality information will be available to Canadian health authorities, health care providers, manufacturers, and Canadians. This initiative will also lead to improved communication within the health-sector, will help Health Canada better understand and monitor medical device safety, and allow timely provision of more accurate information in response to internal and external stakeholders' requests for information.
By May 2018, Health Canada will provide manufacturers with a list of their medical devices associated with active medical device licences. 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. 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.
Health Canada encourages all 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. For more information on the GMDN Agency, please visit the Agency's web site.
Questions or concerns regarding this notice should be directed to:
Medical Devices Bureau - General Inquiries Contact Information E-mail: MDB_Enquiries@hc-sc.gc.ca
Teletypewriter: 1-800-465-7735 (Service Canada)
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