Industry News
The latest medical device regulatory news, clinical trials, and market insights
New Clinical Trial Explores tVNS in MDD for Motivation and Insulin Sensitivity
The University of Bonn has announced an upcoming clinical trial examining the effects of transcutaneous non-invasive vagus nerve stimulation (tVNS)…
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,…
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…
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,…
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…
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…
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Health Canada has launched a consultation process for its draft guidance document concerning the management of applications for medical device…
Health Canada Seeks Feedback on Draft Guidance for Co-Packaged Drug Products
On September 29, 2025, Health Canada announced a public consultation regarding draft guidance on co-packaged drug products.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…
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…
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…
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…
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…