Worldwide: Life Sciences, Biotechnology & Nanotechnology

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Welcome to the Mondaq Food, Drugs, Healthcare, Life Sciences homepage, here you will find thought leadership articles, podcasts, videos and webinars providing insights covering topics such as Food and Drugs Law, Healthcare, Life Sciences, Biotechnology and Nanotechnology.
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
Article
Canada Accelerates Regulatory Modernization
Health Canada's 2025 Red Tape Review has sparked significant regulatory reforms aimed at streamlining drug and medical device approvals through international harmonization. New draft guidance and proposed legislative changes promise to reduce clinical trial requirements for biosimilars, enable faster approvals through foreign reliance pathways, and eliminate redundant licensing requirements for medical device importers.
Canada Healthcare
BJ
Bennett Jones LLP
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