Understanding the SaMD Regulatory Pathway in Canada and the United States
Software that diagnoses, monitors, or treats a health condition carries a different kind of regulatory weight than a physical device. If
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April 25, 2026
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Health Canada’s Regulatory Enrolment Process Is Now Mandatory for Medical Device Licence Applications
As of January 2026, Health Canada’s Regulatory Enrolment Process (REP) is mandatory for all Class II, III, and IV medical device licence (MDL)
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March 30, 2026
Your Health Canada eMCE Update For 2022
Manufacturers and companies exporting medical devices from Canada may be asked by foreign customers or foreign governments to supply certification
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February 5, 2022