Medical Devices Regulations

18 Dec 2025

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

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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…

30 Oct 2025

Understanding MDSAP and Its Role in Canadian Market Access

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The Medical Device Single Audit Program (MDSAP), developed by the International Medical Device Regulators Forum (IMDRF), is a harmonized audit framework that allows a single ISO 13485:2016 audit, conducted by an approved Auditing Organization (AO), to meet the quality management system (QMS) requirements of multiple regulatory authorities simultaneously. In Canada, MDSAP serves as the recognized mechanism…