On June 24, 2025, the Global Harmonization Working Party (GHWP) officially withdrew as a member of…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
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…
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…
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.…
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…
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…
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Health Canada has launched a consultation process for its draft guidance document concerning the management of…
Health Canada Seeks Feedback on Draft Guidance for Co-Packaged Drug Products
On September 29, 2025, Health Canada announced a public consultation regarding draft guidance on co-packaged drug…
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,…
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…