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  Health Canada & GMDN

Health Canada is adopting the Global Medical Device Nomenclature (GMDN) system to improve availability, access, and information quality. The decision 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.

 

GMDN 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.

 

By May 2018, Health Canada 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 license application and license amendment forms. Once these forms are available, applicants will be asked to provide the GMDN data as part of all new applications and license amendment applications.

 

The announcement is available from https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/announcements/notice-global-medical-device-nomenclature.html

 

 

 
 
 
 
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