Medical Device Establishment Licence (MDEL)
What is an MDEL?
A Medical Device Establishment Licence (MDEL) is the licence required by persons who import or distribute (at the wholesale level) medical devices in Canada, or who manufacture Class I devices in Canada.
The MDEL is separate from the Device Licence:
- The Device Licence is held by the manufacturer and authorises a specific device to be sold in Canada
- The MDEL is held by the establishment and authorises an entity to carry out regulated activities (importing, distributing, manufacturing Class I)
Who needs an MDEL?
| Party | MDEL required? |
|---|---|
| Importer (any class of device) | Yes |
| Wholesale distributor (any class) | Yes |
| Canadian manufacturer of Class I devices | Yes |
| Canadian manufacturer of Class II–IV (also distributing) | Yes |
| Retailer selling directly to end users only | No |
| Foreign manufacturer | No (but needs Device Licence) |
| Healthcare institution using devices | No |
What an MDEL covers
An MDEL specifies the regulated activities covered:
- Importing — bringing devices into Canada from outside Canada
- Distributing — wholesale distribution of devices within Canada
- Manufacturing (Class I) — making Class I devices for sale in Canada
All activities your establishment performs must be listed on the MDEL.
QMS requirements for MDEL holders
MDEL holders must maintain a Quality Management System that addresses, at minimum:
- Complaint handling
- Distribution records
- Recall procedures
- Mandatory problem reporting
The QMS requirements for importers and distributors are less extensive than those for manufacturers, but must be adequate to ensure traceability and effective recalls.
How to apply
- Register for a Health Canada online account (if not already registered)
- Submit the MDEL application via the Health Canada e-Submission portal (HRES)
- The application includes company information, regulated activities, and device types
- Annual MDEL fee must be paid
Maintaining your MDEL
MDEL holders must:
- Notify Health Canada within 30 days of changes to the establishment, activities, or device types
- Pay annual MDEL fees
- Maintain adequate distribution records
- Report mandatory problems to Health Canada
- Co-operate with Health Canada inspections
Legislative source: Medical Devices Regulations, SOR/98-282, ss 44–57 (Establishment Licences)