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…
Regulatory Affairs
Global updates on medical device regulation and quality.
441 articles
441 articles in Regulatory Affairs
Canada
Canada
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…
Canada
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Health Canada has launched a consultation process for its draft guidance document concerning the management of applications for medical device…
Canada
Health Canada Seeks Feedback on Draft Guidance for Co-Packaged Drug Products
On September 29, 2025, Health Canada announced a public consultation regarding draft guidance on co-packaged drug products.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…
Canada
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…
Canada
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…
Canada
Simplifying Application Pathways for Medical Device Manufacturers: Latest Health Canada Guidance
Medical device manufacturers in Canada now have updated guidance to help navigate application types under the Medical Devices Regulations. Health…
Canada
Health Canada Streamlines Regulations to Reduce Administrative Burden
On September 29, 2025, Health Canada and the Public Health Agency of Canada announced a sweeping review of regulations and…
Canada
Health Canada Releases 2024-25 Medical Devices Performance Report: Key Metrics on Timeliness and Standards
Health Canada’s Medical Devices Directorate has published its Annual Performance Report for the 2024-25 fiscal year, offering a detailed analysis…
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