Medical Device Establishment Licence

09 Apr 2026

How to Choose the Right Medical Device Licensing Pathway for Efficient Market Entry into Canada

Medical DevicesHealth Canada medical devices, in vitro diagnostic devices Canada, IVDD Canada, MDEL, MDL, Medical Device Establishment Licence, medical device licence Canada, medical device regulatory pathway Canada, private label medical devices

Selecting the appropriate regulatory pathway for a medical device in Canada is a foundational market-access decision that shapes far more than initial licensing. It directly influences regulatory risk, evidence depth, quality system readiness, lifecycle change control, and cross-jurisdictional launch sequencing. For quality, clinical, and product development teams, as well as technical manufacturers,…

18 Dec 2025

Health Canada Proposes Changes to Medical Device Establishment Licensing (MDEL): What Importers, Distributors, and Manufacturers Need to Know

Medical Deviceshealth canada, MDEL, MDEL amendments, Medical device distributors, Medical Device Establishment Licence, Medical device importers, medical device licensing Canada, Medical Devices Regulations

On November 8, 2025, Health Canada published proposed amendments to the medical device establishment licensing framework in the Canada Gazette, Part I. The consultation is open for stakeholder feedback until January 17, 2026. If you hold, or are planning to apply for, a Medical Device Establishment Licence (MDEL), these proposed changes…