Canada medical device registration timeline
Source-linked clocksHealth Canada (Health Canada) review clocks and end-to-end planning ranges, using the 4-class (I, II, III, IV) classification system.
| Class / pathway | Review clock | Planning total | With prior approval | Provenance |
|---|---|---|---|---|
| Class I(MDEL Only (no device license)) MDEL performance standard: 120 calendar days to issue a decision on a new, annual licence review, or reinstatement application | 4 months | 2-3 months | — | Verified |
| Class II(Device License) First-review service standard: 15 calendar days for the licence application (also 15 for amendments and private-label applications) | 2 weeks | 1-1.5 months | — | Verified |
| Class III(Device License with clinical data) First-review service standard: 60 calendar days for the licence application (near-patient IVDs included); manufacturing and significant non-manufacturing changes also 60 | 2 months | 3-4 months | — | Verified |
| Class IV(Device License) First-review service standard: 75 calendar days for the licence application and Class IV changes | 2.5 months | 4-5 months | — | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesPlanning steps and estimates; these are not regulator deadlines.
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.
- MDEL (Establishment License)
- MDSAP certification (Class II-IV)
- Canadian Importer (for foreign manufacturers)
- Bilingual labeling (English/French)
- Investigational testing authorization applications decided within 30 calendar days (non-cost-recovered)
- A new or modified QMS certificate for a licensed device has to reach the Minister within 30 days of issue (MDR s. 43.1)
MDSAP: MANDATORY for Class II-IV - must obtain before submission
Reviewed 2026-08-30. End-to-end totals remain planning estimates.