Establishment licence: MDEL
Assess manufacturer, importer or distributor activities and exemptions. Class I manufacturers and importers or distributors of devices generally require an MDEL, subject to applicable exemptions.
CA · Health Canada
Canada MDEL and MDL support
Distinguish establishment licensing from device licensing before planning classification, applications and ongoing maintenance.
How SUNGO supports your project
Device licence: MDL
Class II, III and IV devices require device licensing. Organise classification-specific evidence and application requirements. An MDEL does not replace an applicable MDL.
Procedures and applications
Review establishment, manufacturer and activity information, together with applicable complaint, recall and record-control procedures. Support applications and additional-information coordination.
Annual review and changes
Support MDEL annual licence review, information changes and maintenance, including the annual review deadline before April 1. Plan MDL lifecycle work separately.
An MDEL is an establishment licence, not approval of each product or a waiver of quality-system and post-market obligations. Assess applicability against business activities and device class.
AFTER THE INITIAL DISCUSSION
Build a product-specific document plan
You do not need every document for the first enquiry. We identify gaps after understanding your product and target market.
Product name, intended purpose and proposed classification
Business role and supply-chain activities
Manufacturer and relevant establishment details
Quality-system evidence and complaint and recall procedures
Specific requirements are subject to product assessment and the competent authority’s current regulations.
Health Canada · About medical devices ↗ · Health Canada · MDEL annual licence review ↗
MDEL application process
- 01
Confirm application information
- 02
Submit the application
- 03
Pay fees as notified
- 04
Receive the licence upon approval
Specific requirements are subject to product assessment and the competent authority’s current regulations.
INITIAL CONSULTATION
Start with two things
Send your product name and instructions for use, and tell Serena which market you are considering.
- Product name
- Instructions for use