Canada Medical Device Registration
Health Canada (Health Canada) approval timelines and requirements
Canada Medical Device Registration Overview
Canada medical device registration through Health Canada typically takes 2-3 months for Class I devices. The official Health Canada target is 4 months, but realistic timelines include preparation, documentation review, and potential questions from regulators.Canada uses a 4-class (I, II, III, IV) risk-based classification system. Foreign manufacturers must appoint a Canadian Importer to register devices in Canada. Health Canada accepts MDSAP certification, which mandatory for class ii-iv - must obtain before submission. Registration is valid for Annual license fee renewal.
Canada uses a 4-class (I, II, III, IV) risk-based classification system.
Class I
MDEL Only (no device license)
• No device license required
• Only MDEL (Establishment License)
Class II
Device License
• MDSAP mandatory since 2019
• Fastest major market for Class II
Class III
Device License with clinical data
• MDSAP mandatory
• Clinical data required
Class IV
Device License
• MDSAP mandatory
• Most rigorous review
Existing approvals from other regulatory authorities can accelerate your Canada registration.
- MDEL (Establishment License)
- MDSAP certification (Class II-IV)
- Canadian Importer (for foreign manufacturers)
- Bilingual labeling (English/French)
Annual license fee renewal
MANDATORY for Class II-IV - must obtain before submission
Canada Medical Device Registration Process
Step-by-step Health Canada registration process. Total estimated timeline: 2-3 months.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by Health Canada. Appoint a Canadian Importer.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to Health Canada including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksHealth Canada reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
4 monthsIn-depth technical assessment of device safety and performance. Health Canada may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, Health Canada issues Canada market authorization certificate.
Timelines are estimates based on 2024-2025 data. Last updated: 2025-12-01.