MDSAP
2 articles
Health Canada REP and CESG: Mandatory Digital Submissions for Medical Device Licences (Class II–IV), IMDRF ToC Format, XML Templates, and the New Submission Workflow Effective April 2026
Health Canada has mandated the Regulatory Enrolment Process (REP) and Common Electronic Submissions Gateway (CESG) for all Class II, III, and IV medical device licence applications, amendments, and regulatory transactions as of April 1, 2026. PDF forms and email submissions are no longer accepted. Manufacturers must use structured XML templates, submit via CESG, and comply with the IMDRF Table of Contents format. This guide covers REP architecture, the Company-Dossier-Device enrolment sequence, what changed from the old process, what's excluded, step-by-step filing instructions, and practical implications for global medical device manufacturers entering the Canadian market.
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.