Health Canada MDL SOP + Application Checklist — SOR/98-282 (Canada)

Process Package — Marketing Authorization Canada (Health Canada)

Complete framework for Health Canada MDL and MDEL. Covers Schedule 1 classification (16 medical device rules), MDL application by class, MDEL for importers/distributors, MDSAP certificate as mandatory QMS evidence, Annual Licence Review (April 1 deadline), bilingual EN/FR labeling, and faxed amendments.

What’s included:

• SOP-REG-CA Marketing Authorization Canada — full procedure: Schedule 1 classification, MDL pathway by class (II/III/IV), MDEL for importers, MDSAP certificate as QMS evidence per §32(2), bilingual EN/FR labeling requirements, ALR process (April 1 hard deadline), faxed amendments, recall and Foreign Risk Notification (cross-reference to vigilance).
• F-REG-CA.1 Canadian Classification + MDL Application Checklist (Word) — combined worksheet with classification rationale per Schedule 1, scalable MDL application checklist for Class II/III/IV, and a senior officer attestation (the personal regulatory commitment required by Health Canada).

Why this package: Canada has a unique senior officer attestation requirement and the April 1 ALR deadline that, if missed, automatically cancels your MDL. This package builds those obligations into your QMS so they don’t get missed.

Format: Microsoft Word
Updated: May 2026 — includes SOR/2024-136 amendments
Delivery: Instant download after purchase