Health Canada Medical Device Registration

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Health Canada Medical Device Classification

The Health Canada Medical Device classification system is borrowed significantly from the European Union’s Council Directive 93/42/EEC. Many of the rules and interpretations of terms are like, those proposed by the European Union. It does not necessarily hold true, however, that a Medical Device classified in one class according to the European Union’s classification system will be classified in the same class based on the Canada Medical Device classification system. Applicant must follow the rules set out in the Regulations to determine the appropriate classification for their device in Canada.

The following indicators of risk posed by a given device were used to create the Canadian classification rules:  degree of invasiveness, duration of contact, body system affected, and local versus systemic effects.

Device ClassRisk
ILow
IILow-Moderate
IIIHigh-Moderate
IVHigh

Canada Authorized Representative

There is no requirement for the manufacturer to appoint an Authorized Representative in Canada. The distributor, however, shall comply with the Health Canada requirements for Good Distribution Practices (GDP).

Medical Device Registration-Canada

There are two pathways for medical device registration in Canada:

Medical Device Establishment License (MDEL): Class I devices can apply for Medical Device Establishment License Canada (MDEL) by preparing mandatory procedures and paying Health Canada fees.

Medical Device License (MDL): Class II, III, and IV devices shall apply for a Canadian Medical Device License (MDL) application. The document requirements for each of the device class vary.

Process flow

Post Approval Device Life Cycle Management

Freyr supports foreign manufacturers in end-to-end Medical Device lifecycle Management, including post approval activities, such as:

  • Post approval change management - modifications to existing medical device approvals such as, addition of new variants, accessories; addition of new indications of use among others
  • Maintenance of approvals and registration through timely payment of administrative and registration fees
  • Renewal of licenses
  • Liaising between Health Canada and the manufacturer

Summary

RiskDevice ClassQMS AuditRegulatory PathwayDocument RequirementsHealth Canada Timelines
LowINAMDEL
  • MDEL application
  • QMS procedures
NA
Low-ModerateIIMDSAP certificateMDL
  • MDL application
  • Fee form
  • Labeling documents
  • Declaration of Conformity (Doc)
  • MDSAP certificate
15 Days
High-ModerateIIIMDSAP certificateMDL
  • MDL application
  • Declaration of Conformity (Doc)
  • ISO 13485:2016 certificate with MDSAP certificate
  • Labeling
  • Technical files as per IMRDF
60 Days
HighIVMDSAP certificateMDL
  • MDL application
  • Declaration of Conformity (Doc)
  • ISO 13485:2016 certificate with MDSAP certificate
  • Labeling
  • Technical files as per IMRDF
75 Days

Freyr Expertise

  • Health Canada Medical Device Classification and grouping services
  • Medical Device Registration, Canada
  • Pre-Submission meetings with Health Canada
  • MDSAP, Canada 
  • Distributor Identification/Qualification of distributor for compliance with Health Canada requirements
  • Medical Device Establishment Licence Canada (MDEL)
  • Medical Device Licensing in Canada (MDL)
  • Post Approval Change Management
  • Labeling services as per Health Canada labeling requirements for Medical Devices

Our Location in Canada

100 Consilium Place, Suite 200,
Scarborough, M1H 3E3,
Canada