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January 3, 2026
Approximately 5 minutes
How to Apply for a Medical Device Establishment Licence (MDEL) – Health Canada Guidance
How to Apply for a Medical Device Establishment Licence (MDEL) – Health Canada Guidance
Overview of the Application Process
Applications for a Medical Device Establishment Licence (MDEL) are submitted electronically through the Medical Devices Online portal. The process is mandatory for establishments that import, distribute, or manufacture Class II, III, or IV medical devices in Canada (unless exempt). The application must demonstrate that the establishment has adequate quality management procedures to ensure device safety, effectiveness, and compliance with the Medical Devices Regulations. How to Apply for an MDEL - Canada.ca
Step-by-Step Application Steps
-
Create or Access an Account
Register for a GCKey or Sign-In Partner account to access the Medical Devices Online portal. -
Start a New Application
Select “Apply for a Medical Device Establishment Licence” in the portal and begin a new submission. -
Provide Establishment Information
Enter legal business name, trade name(s), physical address(es), mailing address, contact details, and ownership structure. -
Specify Activities and Device Classes
Indicate the regulated activities (import, distribute, manufacture) and the classes of devices involved (II, III, IV). List specific device types or families if applicable. -
Describe Quality Management System
Provide a detailed description of procedures for:- Purchasing and supplier verification
- Storage, distribution, and transportation
- Complaint handling and mandatory problem reporting
- Recall procedures
- Document control, training, and internal audits
Reference relevant standards (e.g., ISO 13485 elements) and attach supporting procedures or manuals if requested.
-
List Foreign Manufacturers/Sites (for Importers)
Provide names, addresses, and contact details of all foreign manufacturers or sites involved in production, packaging, labelling, or testing. Include evidence of GMP compliance (e.g., ISO 13485 certificate, inspection report, or quality agreement). -
Pay the Application Fee
Submit the required fee via the portal (current fee schedule applies; annual renewal required). -
Review and Submit
Review the application for accuracy and completeness, then electronically sign and submit.
Required Supporting Documents
- Quality system procedures or manual (summary or full version).
- Quality agreements with foreign manufacturers (for importers).
- Evidence of foreign site GMP compliance (e.g., certificates, audit reports).
- Organizational chart showing quality responsibilities.
- List of devices handled (optional but recommended).
Processing and Decision
- Health Canada acknowledges receipt and reviews for completeness within 10 working days.
- Incomplete applications are returned with reasons.
- Complete applications undergo full review; processing time is typically 30 calendar days.
- Upon approval, the MDEL is issued with a licence number and effective date.
After Submission
- Respond promptly to any requests for additional information.
- Notify Health Canada of changes (e.g., new activities, address) via amendment application.
- Prepare for potential pre-licensing inspection.
- Maintain all records and procedures for ongoing compliance and renewal.
Common Pitfalls to Avoid
- Incomplete quality system descriptions.
- Missing or inadequate foreign site compliance evidence.
- Failure to list all relevant activities or device classes.
- Not paying fees or submitting via the correct portal.
This guidance ensures applicants understand and complete the MDEL application correctly, supporting safe and compliant medical device supply in Canada. Full instructions, templates, fee details, and portal access are available in the official Health Canada MDEL application guidance. How to Apply for an MDEL - Canada.ca
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