Canada Medical Device Registration (Health Canada – Medical Devices Bureau)

1. Regulatory Authority & Legal Framework

Medical devices in Canada are regulated under:

• Food and Drugs Act
• Medical Devices Regulations (SOR/98-282)
• Health Canada – Medical Devices Directorate (MDD)
• Quality Systems (ISO 13485:2016 CMDCAS → MDSAP)
• Mandatory Problem Reporting (MPR)
• UDI implementation (phased 2025 onward)

Canada was the first country to adopt MDSAP (Medical Device Single Audit Program) as mandatory for quality systems.

2. Device Classification (Class I / II / III / IV)

Canada uses a risk-based 4-class system aligned with EU/GHTF:

Classification rules follow Schedule 1 of the Medical Device Regulations.

3. Registration Requirements & Pathways

Canada uses Medical Device Licences (MDL) for Class II/III/IV and Establishment Licences (MDEL) for companies involved in importing/distribution.

3.1 Medical Device Establishment Licence (MDEL)

Required for:

• Manufacturers (Class I only)
• Importers
• Distributors

MDEL requirements:

• QMS procedures
• Complaint handling & recalls
• Record keeping
• Annual renewal

Foreign manufacturers do NOT need MDEL, but their Canadian importer must have it.

3.2 Medical Device Licence (MDL) – Class II/III/IV

Device-specific licence required for:

• Class II
• Class III
• Class IV

MDL application includes:

• Safety & performance evidence
• Technical documentation
• Labeling
• Clinical evidence (Class III/IV)
• MDSAP certificate (replaces old CMDCAS)

3.3 Pathways by Risk Class

Class I

• No MDL required
• Manufacturer registers via MDEL (or uses Importer MDEL)
• Fastest route
• No QMS audit required

Class II

• MDL required
• Requires MDSAP audit by recognized body
• Evidence of compliance with Essential Principles
• Review typically administrative

Class III

• Moderate-high risk
• Requires MDL
• Technical & clinical evidence required
• Comparative/equivalence data accepted

Class IV

• Highest risk (implants, surgical robots, complex active devices)
• Requires full MDL
• Strong clinical evidence required
• Summary of Safety & Effectiveness (SSE) typically needed
• QMS audited under MDSAP

4. Dossier Requirements (MDL Submission)

Canada follows a structure similar to EU MDR & IMDRF:

Administrative Documents

• Application form (FRM-0292)
• Fee Form
• MDSAP certificate
• Canadian representative letter
• Device identifiers (model list)

Technical Documents

• Device description & intended use
• Essential Principles (Safety & Effectiveness)
• Risk management (ISO 14971)
• Software documentation (IEC 62304 + cybersecurity)
• Electrical safety & EMC (IEC 60601)
• Sterilization validation (if sterile)
• Biocompatibility testing (ISO 10993)
• Performance testing
• Clinical evidence (Class III/IV)
• Labeling in English or French

Canada accepts much of the technical evidence prepared for CE/FDA.

5. Fees & Timelines

5.1 Health Canada Fees (2025 typical)

• Class II MDL: ~CAD 500
• Class III MDL: ~CAD 10,000
• Class IV MDL: ~CAD 35,000
• MDEL: ~CAD 5,000 (annual renewal)

Small business reductions (25%–50%) available.

5.2 Review Timelines

• Class I: Immediate (MDEL)
• Class II: 15–30 days
• Class III: 75 days (target)
• Class IV: 90 days (target)

Actual timelines vary depending on dossier quality and HC queue.

6. Labeling Requirements

Labeling must comply with Sections 21–23 of the Regulations:

• Device name/model
• Manufacturer name & address
• Canadian importer name/address
• Class-specific statements
• Directions for use
• Storage/handling instructions
• Sterility/expiry date
• UDI (phased implementation 2025+)

Language: English, French, or bilingual.

7. Canadian Import & Post-Market Requirements

Importation

• Only companies with MDEL may import
• Product must have valid MDL (Class II/III/IV)
• Customs clearance under CBSA

Post-Market Surveillance

• Mandatory Problem Reporting (MPR)
  • Serious injury: 10 days
  • Death: 2 days
• Recall procedures
• Complaint handing
• Annual licence renewal
• QMS audits (under MDSAP)

8. Consulting Notes for Your Device Portfolio

9. Advantages of the Canada Market

• Predictable & transparent regulatory system
• Fast review (Class II in ~2–3 weeks)
• Strong recognition of CE/FDA scientific data
• MDSAP certification accepted globally (US, Japan, Australia, Brazil)
• Bilingual market (EN/FR) with high demand for imported technology