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Economic Operators & Importers
Manufacturer, Importer & Supply-Chain Compliance
Canadian market access depends on more than the manufacturer’s device licence. The roles of the importer and distributor, MDEL status, traceability, complaint routing and regulatory responsibilities must be clear across the supply chain.
Supply Chain & Importer Compliance Framework
Legal manufacturer and establishment-role assessment
Importer and distributor MDEL requirements and verification
Verification of device licensing (MDL/MDEL) before import or commercial sale
Distribution records, lot-level tracking, and supply-chain traceability
Complaint communication workflows between Canadian partners and the legal manufacturer
Mandatory problem reporting responsibilities and timeline enforcement
Recall responsibilities, Health Canada notifications, and effectiveness checks
Storage, handling, temperature monitoring, and transport controls
Quality agreements, regulatory contracts, and responsibility mapping
Change notification protocols and licence maintenance interfaces
Expert Focus:
A compliant supply chain requires clear ownership of the regulatory decisions: who verifies licence status, who receives complaints, who assesses reportability, who communicates recalls and who maintains the records Health Canada may request.
Align Your Canadian Import and Distribution Operations
Our team drafts quality agreements, audits importer standard operating procedures, and verifies MDEL compliance.