Canada
4 articles
Health Canada Medical Device Regulation Reform 2026: Terms & Conditions, AI/ML Guidance, REP, and Lifecycle Oversight
Health Canada's 2026 regulatory reforms introduce expanded Terms & Conditions (T&C) powers for Class II–IV devices, new AI/ML-enabled medical device guidance, mandatory Regulatory Enrolment Process (REP), IMDRF Table of Contents requirements, and updated significant change guidance. This guide covers every major change effective January–April 2026 and what foreign manufacturers must do to maintain Canadian market access.
MDSAP Audit Preparation: Complete Guide for Medical Device Manufacturers (2026)
Everything you need to prepare for an MDSAP audit — the 2026 updated audit approach (AU P0002.010), QMSR alignment, step-by-step preparation checklist, costs, timelines, and common nonconformities.
Health Canada Medical Device License: The Complete Guide
How to obtain a Medical Device License from Health Canada — classification, MDSAP requirements, MDEL, application process, fees, and practical guidance for the Canadian market.
MDSAP Audit: The Complete Guide to the Medical Device Single Audit Program
Everything about MDSAP — the single audit program covering FDA, Health Canada, TGA, ANVISA, and MHLW. Audit process, grading, preparation, costs, and how to pass.