Health Canada Medical Device Registration Service
Registration support for Class I–IV medical devices entering Canada, including MDEL/MDL pathway coordination and MDSAP-related preparation where applicable. Service scope is matched to the device risk class and manufacturer role.
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Service Overview
Health Canada applies a risk-based classification system for medical devices. EXIMIO can organize the registration route around the applicable device class, including establishment licensing, device licensing, quality-system evidence and submission coordination represented in the source workflows.
Process Flow & Timing
Select a route below to view the workflow and timing.
Class I
Official authority service standard120 calendar daysOfficial authority standard (MDEL)
Health Canada Class I Registration
Company MDEL Application
Prepare MDEL Application Materials
Submit Application & Pay Fee
Health Canada Review
MDEL / Authorization
Class II
Official MDL review standard15 calendar daysOfficial authority standard
Health Canada Class II Registration
Company MDEL Application
Prepare MDEL Materials
Submit & Pay Fee
MDEL Review Passed
Product MDL Application
MDSAP Certification
Prepare MDL Materials
Submit & Pay Fee
MDL Review Passed
Establish QMS
Certification Body Audit
Corrective Actions
Certificate Issued
Market Authorization / Certificate
Class III–IV
Official MDL review standardsClass III 60 · Class IV 75 daysOfficial authority standard
Health Canada Class III / IV Registration
Company MDEL Application
Prepare MDEL Materials
Submit & Pay Fee
MDEL Review Passed
Product MDL Application
MDSAP Certification
Prepare MDL Materials
Application & Fee
Premarket Review File
Health Canada MDL Review
Establish QMS
Certification Body Audit
Corrective Actions
Certificate Issued
MDL / Certificate
Regulatory Basis & Official References
Legal and regulatory references below link directly to the relevant government regulator, official legislation database or official legal text. The applicable provisions should still be confirmed against the device classification, intended purpose and market-access route at project start.
LawMedical Devices Regulations (SOR/98-282)Current consolidated Canadian medical-device regulation.Open official source ↗LawSOR/98-282 §25Class I sale/import licensing framework and applicable exceptions.Open official source ↗LawSOR/98-282 §26Requirement for Class II, III and IV medical devices to hold a medical device licence before import/sale, subject to the regulation.Open official source ↗LawSOR/98-282 §32Required content for an application for a medical device licence.Open official source ↗LawSOR/98-282 §44Medical Device Establishment Licence (MDEL) requirement and exceptions.Open official source ↗Official GuidanceHealth Canada MDL Review ProcessCurrent review stages and Class III / IV target performance standards.Open official source ↗Official GuidancePerformance Standards for Medical-Device FeesOfficial Class II–IV MDL and MDEL performance standards.Open official source ↗
Related Regulatory Support
Classification review, MDSAP preparation and technical-document support can be coordinated with the registration service.
EXIMIO Support
Contact EXIMIO BIOTEC for pathway confirmation, document-gap review, submission planning, technical-document preparation, authority communication support and a project-specific quotation.