MDALL (Canada)

What is MDALL?

MDALL is Health Canada's public Medical Devices Active Licence Listing and related licence-history search. The active database identifies Class II, III and IV devices currently licensed for sale in Canada, including the licence holder, licence number, device name and identifiers. The archive provides historical records for licences that are no longer active, so users must distinguish an archived result from current authority to market.

What appears in MDALL — and what does not?

Class I devices do not receive product-specific Medical Device Licences and therefore do not appear in the active product listing. Instead, manufacturers, importers and distributors may need a Medical Device Establishment Licence depending on their activities and applicable exemptions. A Canadian diligence check can therefore require two different questions: whether the Class II, III or IV product has an active MDL, and whether the establishments performing licensable supply-chain activities hold the required MDEL.

Who uses MDALL, and for what?

Healthcare facilities and purchasers use MDALL to verify that a device is currently licensed. Importers and distributors can compare licence names and device identifiers with the product they intend to supply, while manufacturers can confirm how a licence family is represented publicly. The database is strong evidence of licence status but is not a substitute for reading the licence scope, conditions and current labeling. A similar product name alone does not prove that a specific identifier is covered.

How does a device get into MDALL and stay active?

Health Canada issues an MDL after the applicable Class II, III or IV licensing requirements are met. Class II applications and higher-risk applications have different evidence and review requirements, and quality-management-system evidence includes MDSAP certification to ISO 13485 where required. Manufacturers of licensed devices must complete the annual licence-renewal process before 1 November and pay the applicable right-to-sell fee; failure can lead to cancellation. The Canada market page covers classification, application and renewal together.