Health Canada MDEL Renewal Checklist for MDEL ALR
MDEL annual license review (ALR) is a yearly renewal process for companies manufacturing, importing, or distributing medical devices in Canada. Health Canada oversees the ALR process. This review process ensures that MDEL holders remain consistently compliant with the...
CE Marking for Cardiovascular Medical Devices: Your Guide
CE marking is mandatory for marketing your cardiovascular medical devices in the EU market. It demonstrates compliance with EU MDR guidelines. The process of CE marking for cardiovascular medical devices is a rigorous, multi-step pathway. It ensures safety,...
India Eases Medical Device Rules: EU Added to Waiver List
India has eased medical device rules by removing the requirement for a separate loan licence when manufacturers outsource sterilisation. However, the sterilisation facility should hold a valid licence, with a six‑month transition period to update labels. Additionally,...