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Canada: Regulations Amending the Medical Devices Regulations

Updated on : 16-11-2025

Canada: Regulations Amending the Medical Devices Regulations

This proposal delivers on Phase II of Health Canada’s commitments set out in the Departmental Forward Regulatory and Stock Review Plans to modernize the Medical Device Establishment Licensing (MDEL) framework, while enabling the oversight to better manage emerging health and safety risks. The proposed amendments would:  remove the requirement for importers with an MDEL to import from foreign distributors with an MDEL. require all MDEL applicants to provide supplier information as part of their MDEL application and to update the supplier information once a year at annual licence review Make explicit the requirement for manufacturers, importers and distributors to establish, implement and maintain all documented procedures relevant to their safety management activities.Most of the medical devices sold in Canada are imported, with a growing number of suppliers providing medical devices to the Canadian market. This, in addition to experimentation with regulatory flexibilities during the COVID-19 pandemic, demonstrates a need to update the current framework to allow Health Canada to continue to provide efficient, effective, and agile oversight of medical devices to protect the health and safety of people in Canada.  

Download: Canada: Regulations Amending the Medical Devices Regulations

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