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Medical Devices updates: Phase II consultation on Medical Devices Regulations amendments, medical device licences guidance and IMDRF table of contents guidance

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On November 17, 2025, Health Canada proposed Phase II amendments to the Medical Devices Regulations (MDR). The first phase of amendments came into force on December 14, 2024 and relate to recalls, modernizing medical device establishment licence (MDEL)…
By: Smart & Biggar

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