MDALL vs MDEL: Health Canada Medical Device Licence and Establishment Licence Guide

Quick answer

Health Canada issues two different permissions that importers and distributors often confuse:

• Medical Device Licence (MDL) — product-level licence for Class II, III, and IV devices. Searchable in MDALL.
• Medical Device Establishment Licence (MDEL) — company-level licence for establishments that import or distribute devices (and manufacturers of Class I). Listed in the MDEL database.

Class I devices do not require an MDL and are not listed in MDALL. Importers/distributors of all classes may still need an MDEL. An MDEL does not approve specific products.

Who this applies to

• Importers bringing medical devices into Canada
• Distributors selling devices in Canada
• Manufacturers of Class I devices (MDEL applies)
• Regulatory affairs verifying supplier compliance

MDL vs MDEL comparison

MDALL — what it contains

The Medical Devices Active Licence Listing (MDALL) includes Class II, III, and IV medical devices that hold an active MDL.

Use MDALL to:

• Verify a device is licensed before import/distribution
• Identify the licence holder for Class II–IV devices
• Confirm device name, class, and licence number

Search: https://health-products.canada.ca/mdall-limh/?lang=eng

Health Canada's MDALL API documentation confirms Class I devices are not in MDALL because they do not require a device licence.

MDEL — what it contains (and does not)

The Medical Device Establishment Licence (MDEL) listing shows establishments licensed to import, distribute, or manufacture (Class I) medical devices.

Critical distinction from Health Canada:

An MDEL does not constitute approval of a specific device and does not list products under the establishment.

Use MDEL to verify a supplier is licensed as an establishment — then use MDALL to verify each Class II–IV device.

Search: https://health-products.canada.ca/mdel-leim/

Class I special case

• No MDL required → device not in MDALL
• Importers/distributors still typically need MDEL
• Manufacturers of Class I devices need MDEL per Health Canada establishment rules

Step-by-step verification workflow for importers

1. Identify device class (I, II, III, or IV).
2. If Class II–IV: search MDALL for the device licence and confirm active status.
3. Verify the licence holder matches your supply chain (manufacturer or authorized importer).
4. Search MDEL for your importer/distributor establishment — confirm valid MDEL.
5. For Class I: skip MDALL; confirm supplier MDEL and Canadian compliance documentation.
6. Health Canada FRM-0292 MDEL application instructions direct importers/distributors to use MDALL when verifying Class II–IV manufacturers.

Checklist

• Device class determined
• MDALL searched for Class II–IV devices
• Active MDL confirmed for each SKU
• MDEL verified for importing/distributing establishment
• Not treating MDEL as product approval
• Class I path documented (no MDALL entry expected)
• Licence holder matches supply agreement

Common pitfalls

1. Searching MDALL for Class I devices — they will not appear.
2. Assuming MDEL covers product approval — it covers establishment activity only.
3. Skipping MDALL when MDEL is valid — both checks serve different purposes.
4. Relying on expired licences — confirm active status in databases.
5. Mismatch between licence holder and contract manufacturer — trace the legal licence holder.

FAQ

What is the difference between MDALL and MDEL?

MDALL lists licensed Class II–IV devices. MDEL lists licensed establishments that import, distribute, or manufacture Class I devices.

Are Class I devices in MDALL?

No. Class I devices do not require a medical device licence and are not listed in MDALL.

Does an MDEL mean my device is approved?

No. MDEL authorises the establishment; it is not product approval.

Which database should importers check first for Class III devices?

MDALL for the device licence, and MDEL for establishment licensing of supply chain partners.

Where are MDEL application instructions?

Health Canada FRM-0292 MDEL application form and instructions.

Official sources

• Health Canada — About medical devices: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/about-medical-devices.html
• MDALL search: https://health-products.canada.ca/mdall-limh/?lang=eng
• MDALL API documentation: https://health-products.canada.ca/api/documentation/mdall-documentation-en.html
• MDEL listing: https://health-products.canada.ca/mdel-leim/
• FRM-0292 MDEL instructions: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/forms/medical-device-establishment-licence-application-form-instructions-0292.html