Author: Karen Zhou
Health Canada has announced that it is initiating the transition to the Global Medical Device Nomenclature (GMDN) as a medical device categorization method. The goal of this initiative is to improve the availability, access, and quality of information available on medical devices in Canada.
The GMDN is a system of internationally agreed descriptors used to identify medical devices. The purpose of the nomenclature is to facilitate the exchange of medical device information in support of patient safety. Specifically, the nomenclature is used for data exchange between manufacturers, regulators and health authorities; exchange of post-market vigilance information; supporting inventory controls in hospitals; and purchasing and supply chain management. The GMDN database is a constantly evolving database that currently consists of 23,000 active terms covering all major technologies and intended uses.
Health Canada’s decision to use GMDN aligns with the recommendation of the International Medical Device Regulators Forum (IMDRF) as well as the Canadian Government’s Open Government Initiative to make more data and information available to Canadians. By adopting the GMDN, Health Canada has taken another step toward fulfilling its mission to help Canadians maintain and improve their health by ensuring better quality information is available to health authorities, healthcare providers, manufacturers and Canadians. This initiative will also lead to improved communication within the health sector, better understanding and monitoring of medical device safety and timely provision of accurate information in response to requests for information from internal and external stakeholders.
Beginning May 2018, Health Canada began to 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. In addition, Health Canada will be updating device application and amendment forms. When the forms are updated, device applicants will be asked to provide GMDN data as part of new applications and amendment applications. Codes received from manufacturers will be reviewed prior to being added to the internal database. Health Canada may contact the manufacturer for clarification if the codes are incorrect; however, this will not delay processing of applications nor will a screening deficiency be issued.
Health Canada encourages all manufacturers to obtain GMDN membership. However, the agency is aware of the cost for manufacturers to gain membership and therefore will provide assistance in identifying GMDN codes for those unable to. Additional information regarding GMDN can be found on the GMDN agency website.
References:
1. Notice: Improving access to medical devices information (May 22, 2018) https://www.canada.ca/en/health-canada/services/drugs-health-products/international-activities/notice-acss-new-chemical-entities-trial-phase-1.html
2. GMDN Agency https://www.gmdnagency.org/