Health Canada Regulatory Pathways for IVDs: Complete Guide
Health Canada regulates in vitro diagnostic devices (IVDs) under the Medical Devices Regulations. It uses a risk-based classification system (Class I–IV) to determine the applicable regulatory pathways. Class II–IV IVDs require a Medical Device Licence (MDL). On the...
Health Canada Post-Market Surveillance Requirements
Health Canada requires medical device manufacturers to conduct ongoing post-market surveillance. Mandatory summary reports, issue-related analyses, incident reporting, and foreign risk notifications are necessary requirements. Notably, these obligations apply...
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...