Canada - Regulations Amending the Medical Devices Regulations (Establishment Licenses)

​The WTO was notified of the proposed amendments to the MDR under G/TBT/N/CAN/758 on November 13, 2025. The objective of these amendments to the MDR is to modernize the Medical Device Establishment Licensing (MDEL) framework to better respond to a rapidly innovative industry, while maintaining oversight to better manage emerging health and safety risks. These objectives include reducing unnecessary burden to facilitate international alignment, improving Health Canada’s ability to identify and monitor non-compliant medical devices and establishments that may pose a risk of injury to health, and providing certainty with respect to the requirements in the MDR. Further, these amendments align with the objectives of the report on red tape reduction (RTR) and contribute to risk-based regulating. The amendments will remove the requirement for importers with an MDEL to import from foreign distributors with an MDEL. Having a licensed importer in Canada to manage risks to health and safety is sufficient for the traceability of devices when there are safety or quality issues. Persons without an MDEL that import (i.e. retailers and health care facilities) will continue to be required to verify that the foreign distributor whom they import from holds an MDEL. This amendment will more closely align Canada with other jurisdictions and reduce the redundancy in the current licensing scheme. The amendments to the MDR will require all MDEL applicants to provide supplier information as part of their MDEL application and to update the supplier information once a year at the annual license review. This will allow for more targeted and efficient compliance and enforcement actions by maintaining a line of sight on foreign distributors, who will no longer be required to hold an MDEL, if selling through an MDEL holder. To address Health Canada’s compliance and enforcement observations during inspections, the amendments to the MDR will make explicit the requirement for manufacturers, importers and distributors to establish, implement and maintain all documented procedures relevant to their safety management activities. This is critical to help ensure that health and safety risks can be managed once a medical device is on the market.​