Planning to sell your medical device in Canada?
Health Canada is the government body that reviews and approves all medical devices before they can be marketed in the country. Their goal is simple — to make sure all devices are safe, effective, and high quality.
If you are a manufacturer, importer, or distributor, you must understand how Health Canada classifies medical devices and what kind of licence you need.
At OMC Medical, we help companies like yours register their devices smoothly — from the first classification step to final approval.
Understanding Medical Device Classification in Canada
Canada classifies medical devices based on risk — from Class I (low risk) to Class IV (high risk).
Correct classification determines your licensing route, technical documentation, and review timeline.
| Class | Risk Level | Example Devices | Licence Type |
| Class I | Low | Bandages, hospital beds | MDEL (Establishment Licence) |
| Class II | Low–Moderate | Contact lenses, hearing aids | MDL (Device Licence) |
| Class III | Moderate–High | Orthopedic implants, infusion pumps | MDL |
| Class IV | High | Pacemakers, heart valves | MDL |
Why classification matters:
- Determines your application type (MDL or MDEL)
- Affects the level of evidence (clinical or performance data) required
- Impacts review time and fees
📘 Health Canada – Medical Devices Regulations
The Two Main Licence Types
1. Medical Device Establishment Licence (MDEL)
Required for:
- Class I device manufacturers
- Importers and distributors of any device class
Key Points:
- Confirms your organization follows complaint handling, recall, and record-keeping procedures.
- Must be renewed annually.
- Application: Form FRM-0292
2. Medical Device Licence (MDL)
Required for:
- Class II, III, and IV devices
- Submitted by the manufacturer before sale or import
You’ll need to submit:
- Device description and intended use
- Risk analysis and test results
- ISO 13485 or MDSAP certification
- Labels and Instructions for Use (IFU)
Check the official listing of approved devices here: MDALL Database
Steps for Canada Medical Device Registration Process
Here’s a clear breakdown of how to register a medical device in Canada:
Step 1: Identify if your product is a “medical device.”
Check Health Canada’s official definition — it covers anything used to diagnose, treat, or prevent diseases or abnormal conditions.
Step 2: Classify your device.
Use the classification rules to find out whether it’s Class I, II, III, or IV.
If unsure, OMC Medical can help with proper classification.
Step 3: Determine which licence you need.
- Class I → MDEL
- Class II, III, IV → MDL
- Importers/distributors → MDEL
Step 4: Prepare documents.
For MDL applications:
- Technical file with device description, intended use, risk analysis, and test data
- Proof of ISO 13485 certification
- Label and IFU (Instructions for Use)
For MDEL applications:
- Company details and business activities
- Quality system and complaint handling procedures
- Record-keeping and recall procedures
Step 5: Submit your application to Canada
Applications are submitted through Health Canada’s official forms and email channels.
Step 6: Review and approval.
Health Canada reviews your application and may ask for clarifications.
Once approved, your device appears on the Medical Devices Active Licence Listing (MDALL) database.
Step 7: Maintain compliance.
- Report any serious incidents or recalls
- Renew MDEL every year
- Keep technical documents updated
Canada Medical Device Registration Checklist
| ✅ | Step | Assistance from OMC Medical |
| ☐ | Identify product as a medical device | Regulatory assessment |
| ☐ | Determine device classification (I–IV) | Classification guidance |
| ☐ | Identify required licence (MDEL / MDL) | Licence strategy planning |
| ☐ | Prepare technical documentation | File preparation & review |
| ☐ | ISO 13485 / QMS support | QMS setup & certification |
| ☐ | Complete Health Canada forms | Application assistance |
| ☐ | Submit application | Submission coordination |
| ☐ | Respond to Health Canada queries | Liaison & clarification |
| ☐ | Receive licence approval | Verification in MDALL |
| ☐ | Maintain post-market compliance | Ongoing regulatory support |
Why Partner with OMC Medical
At OMC Medical, we simplify the entire Health Canada registration process. Our team of regulatory experts provides:
- ✅ End-to-end support for MDL & MDEL
- 🕒 Faster review turnaround through complete, compliant submissions
- 🌍 Global expertise — we assist manufacturers from India, China, UAE, UK, USA, and more
- 📊 Post-market and vigilance management for long-term compliance
💬 “With OMC Medical, your path to the Canadian market becomes clear, compliant, and confident.”
Final Thoughts
The Canada medical device registration process is structured but manageable when approached with the right knowledge and partner.
By classifying your device correctly, preparing strong documentation, and maintaining compliance, you can access one of the world’s safest and most trusted healthcare markets.
Let OMC Medical handle the complexities — so you can focus on innovation and business growth.
📩 Get in touch with our team today to start your Canada registration journey.
