Health Canada Aligns with IMDRF Standards for Medical Device Applications
In a significant step toward global regulatory alignment, Health Canada has announced it is adopting the International Medical Device Regulators…
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15 articles in Canada
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Health Canada Releases Updated Guidance on Medical Device License Applications
Health Canada has published updated guidelines for managing medical device license applications. These regulations aim to enhance clarity for manufacturers,…
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Health Canada Shares Stakeholder Feedback on Co-Packaged Drug Products Guidance
Health Canada has released insights on stakeholder feedback regarding its draft guidance for co-packaged drug products, reflecting its ongoing commitment…
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Health Canada Updates Terms and Conditions for Class II-IV Medical Devices
Health Canada has announced changes to the terms and conditions (T&Cs) for licences covering Class II-IV medical devices. Effective immediately,…
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Health Canada Updates Food and Medical Device Regulations for Agile Licensing Framework
Health Canada has officially implemented amendments to the Food and Drug Regulations and the Medical Devices Regulations, marking a pivotal…
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Health Canada Proposes Regulations to Combat Health Product Shortages in Canada
Health Canada is taking action to address health product shortages that pose risks to human health. On September 29, 2025,…
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Critical Alert: Biotin Supplementation Linked to False Laboratory Test Results
On September 29, 2025, Health Canada issued an important advisory warning healthcare professionals, clinical teams, and regulatory personnel about the…
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New Guidance from Health Canada on Machine Learning Medical Devices: Pre-Market Requirements Clarified
Health Canada has issued pivotal guidance for manufacturers preparing pre-market applications for machine learning-enabled medical devices (MLMDs) classified as Class…
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Health Canada Seeks Input on New Guidance for Medical Device Licensing Applications
Health Canada has launched a consultation process for its draft guidance document concerning the management of applications for medical device…
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Health Canada Seeks Feedback on Draft Guidance for Co-Packaged Drug Products
On September 29, 2025, Health Canada announced a public consultation regarding draft guidance on co-packaged drug products. Designed to improve…
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Updated Guidance for Medical Mask and Respirator Manufacturers Announced by Health Canada
Health Canada has released updated guidance for manufacturers of medical masks and respirators, impacting clinical, quality, and regulatory teams involved…
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Health Canada Expands eSTAR Pilot Program for Medical Device Submissions
On September 29, 2025, Health Canada announced an important development in its ongoing efforts to streamline medical device submissions. The…
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