Canada Product Registration & Certification
Important Notes
- Mandatory English-French Bilingual Labeling: All product labels must contain English and French information with identical content complying with Canadian official language requirements
- Medical Device License: Medical devices must obtain Health Canada Medical Device License (MDL) for sale, managed by Class I-IV risk classification
- Natural Health Product Dual Licensing: Natural health products require both product license (NPN/DIN-HM) and site license for manufacturing facilities
- Cosmetic Notification Filing: Cosmetics must submit notifications through Health Canada Cosmetic Notification System before marketing ensuring safety information registration
- MDSAP Quality System Certification: Medical device manufacturers require Medical Device Single Audit Program (MDSAP) certification or ISO 13485 certificate
- Post-market Surveillance Obligations: Must establish complete PMS and adverse event reporting system reporting serious incidents to Health Canada
- License Renewal Maintenance: All licenses require periodic renewal; medical device licenses renew every 1-5 years depending on risk class
- Clinical Evidence Requirements: Class III/IV high-risk medical devices require sufficient clinical evidence; natural health products need traditional use or scientific evidence
Canada Specific Requirements
- Strict English-French Bilingual Labeling: All product labels must contain both English and French information reflecting Canadian official bilingual policy
- Medical Device Graded Management: Medical devices follow Class I-IV risk classification system with differentiated registration pathways and regulatory requirements
- Independent Natural Health Product Framework: Natural health products have independent regulatory framework (NHP Regulations) distinct from drugs and medical devices
- MDSAP Quality System Dominance: Medical device quality systems require MDSAP certification recognized by multiple countries including US FDA
- Cosmetic Notification Filing System: Cosmetics follow notification filing system emphasizing corporate responsibility and product safety information transparency
- Scientific Evidence Centrality: Emphasizes scientific evidence and product quality systems with all health claims requiring solid scientific support
- Transparent & Predictable Regulatory Process: Strict but transparent predictable regulatory process with Health Canada providing clear timelines and guidance
Medical Devices Registration
Regulatory Requirements
- Medical Device License (MDL)
- Classification Management by Risk Level (Class I, II, III, IV)
- Medical Device Single Audit Program (MDSAP) Certificate
- Complete Technical Documentation and Test Reports
- Quality Management System Certificate (ISO 13485)
- Clinical Data (Class III, IV devices)
- Biocompatibility Test Reports (if applicable)
- Electrical Safety Certification (if applicable)
- Canadian Authorized Representative
Main Process
- Product Classification Determination
- Technical Documentation Preparation
- Quality System Certification
- MDL Application Submission
- Technical Review
- License Acquisition
Registration Timeline
8-18 months
Official Fees
$3,000 - $15,000
Service Fees
$15,000 - $45,000
Regulatory System Overview
Health Canada
Health Canada
Comprehensively responsible for registration approval, quality supervision, post-market safety monitoring, and market regulation of medical devices, cosmetics, natural health products, and pharmaceuticals. Serves as the supreme health product regulatory authority in Canada.
MDB
Medical Devices Bureau
Responsible for medical device registration approval, technical evaluation, post-market surveillance, and compliance regulation
NHPD
Natural Health Products Directorate
Responsible for natural health product licence approval, product monograph management, and market regulation
Medical Devices Registration Process
Product Classification Determination
Determine medical device risk classification according to Canada Medical Devices Regulations (Class I-IV)
Technical Documentation Preparation
Prepare complete technical documentation including performance testing, biocompatibility, software validation
Quality System Certification
Obtain MDSAP certification or ISO 13485 certificate
MDL Application Submission
Submit medical device license application to Health Canada
Technical Review
Pass Health Canada technical documentation review and conformity assessment
Cosmetics Registration
Regulatory Requirements
- Cosmetic Notification
- Ingredient Safety Assessment Report
- English-French Bilingual Product Labeling
- Good Manufacturing Practice Certification
- Product Information File
- Ingredient Restrictions Compliance Proof
- Adverse Reaction Reporting System
Main Process
- Ingredient Compliance Assessment
- Safety Assessment Completion
- Bilingual Labeling Preparation
- Cosmetic Notification Submission
- GMP System Establishment
Registration Timeline
2-4 months
Official Fees
Free
Service Fees
$5,000 - $15,000
Regulatory System Overview
Health Canada
Health Canada
Comprehensively responsible for registration approval, quality supervision, post-market safety monitoring, and market regulation of medical devices, cosmetics, natural health products, and pharmaceuticals. Serves as the supreme health product regulatory authority in Canada.
MDB
Medical Devices Bureau
Responsible for medical device registration approval, technical evaluation, post-market surveillance, and compliance regulation
NHPD
Natural Health Products Directorate
Responsible for natural health product licence approval, product monograph management, and market regulation
Cosmetics Registration Process
Ingredient Compliance Assessment
Verify all ingredients comply with Canada Cosmetic Ingredient Hotlist requirements
Safety Assessment Report
Prepare product safety assessment report signed by qualified safety assessor
Bilingual Labeling Review
Prepare English-French bilingual labeling compliant with Canadian requirements
Cosmetic Notification
Submit product information through Cosmetic Notification System
Adverse Reaction Monitoring
Establish serious adverse reaction monitoring and reporting system
Natural Health Products (NHP) Registration
Regulatory Requirements
- Product Licence
- Site Licence
- Product Monograph or Traditional Use Evidence
- Good Manufacturing Practice (GMP) Certification
- Safety and Efficacy Evidence
- English-French Bilingual Labeling
- Ingredient Specifications and Purity Proof
- Stability Study Data
Main Process
- Product Classification Confirmation
- Evidence Material Preparation
- Product Licence Application
- Site Licence Application
- Technical Review Coordination
Registration Timeline
6-12 months
Official Fees
$500 - $8,000
Service Fees
$9,000 - $25,000
Regulatory System Overview
Health Canada
Health Canada
Comprehensively responsible for registration approval, quality supervision, post-market safety monitoring, and market regulation of medical devices, cosmetics, natural health products, and pharmaceuticals. Serves as the supreme health product regulatory authority in Canada.
MDB
Medical Devices Bureau
Responsible for medical device registration approval, technical evaluation, post-market surveillance, and compliance regulation
NHPD
Natural Health Products Directorate
Responsible for natural health product licence approval, product monograph management, and market regulation
Natural Health Products (NHP) Registration Process
NHP Classification Confirmation
Confirm product meets Natural Health Product definition and regulatory scope
Evidence Material Preparation
Prepare safety, efficacy evidence, or compliance with approved product monograph
Product Licence Application
Submit NHP product licence application and supporting documents
Site Licence Application
Apply for GMP certification of manufacturing, packaging, labeling sites
Quality System Establishment
Establish quality assurance system compliant with NHP GMP requirements