Canada: Food, Drugs, Healthcare, Life Sciences

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Article
Medical Devices Updates: Mandatory Use Of The Regulatory Enrolment Process For Medical Devices And Updated Guidance Documents Related To The Regulatory Enrolment Process
Health Canada released a notice to industry on April 24, 2026, outlining that manufacturers must use the Regulatory Enrolment Process (REP) and Common Electronic Submission Gateway (CESG) for medical device transactions as of April 1, 2026. As we previously reported, manufacturers of medical devices could voluntarily use the REP and CESG for medical device regulatory transactions as of July 2024.
Canada Healthcare
SB
Smart & Biggar
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Article
Health Canada Seeks Feedback On Phased Implementation Of The Incorporated By Reference List For Ministerial Reliance Order
As previously reported, Health Canada has proposed a Ministerial Reliance Order that would allow Health Canada to rely on decisions of foreign regulatory authorities (FRAs). Health Canada has proposed that the Reliance Order will come into force in summer 2026, at which point Health Canada will consult on an applicable guidance document.
Canada Healthcare
SB
Smart & Biggar
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Article
Medical Devices Updates: Mandatory Use Of The Regulatory Enrolment Process For Medical Devices And Updated Guidance Documents Related To The Regulatory Enrolment Process
Health Canada released a notice to industry on April 24, 2026, outlining that manufacturers must use the Regulatory Enrolment Process (REP) and Common Electronic Submission Gateway (CESG) for medical device transactions as of April 1, 2026. As we previously reported, manufacturers of medical devices could voluntarily use the REP and CESG for medical device regulatory transactions as of July 2024.
Canada Healthcare
SB
Smart & Biggar
See more
Article
Medical Devices Updates: Mandatory Use Of The Regulatory Enrolment Process For Medical Devices And Updated Guidance Documents Related To The Regulatory Enrolment Process
Health Canada released a notice to industry on April 24, 2026, outlining that manufacturers must use the Regulatory Enrolment Process (REP) and Common Electronic Submission Gateway (CESG) for medical device transactions as of April 1, 2026. As we previously reported, manufacturers of medical devices could voluntarily use the REP and CESG for medical device regulatory transactions as of July 2024.
Canada Healthcare
SB
Smart & Biggar
See more