Medical Devices Regulatory Services
in Canada

Overview

Canada, with some of the stringent guidelines, has one of the best Regulatory systems in the world for medical devices. In Canada, all Medical Devices are regulated by Health Canada, Health Products and Food Branch, Therapeutic Products Directorate, Medical Devices Bureau. Health Canada reviews Medical Devices to assess their safety, effectiveness, and quality before being authorized for sale in Canada as per the Medical Device Regulation SOR/98-282, implemented in 1998.

Regulatory Authority: Health Canada 

Regulation: Medical Devices Regulations (SOR/98-282) 

Authorized Representative: Not Required

QMS Requirement: ISO 13485:2016 compliance as Medical Device Single Audit Program (MDSAP)

Assessment of Technical Data: Health Canada 

Validity of License: Unlimited 

Labeling Requirements: Part 21 of MDR (SOR/98-282) 

Submission Format: Paper 

Language: English & French 

Canada Medical Device Classification

The 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 Class

Risk

I

Low

II

Low-Moderate

III

High-Moderate

IV

High

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 in 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 (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

Risk

Device Class

QMS Audit

Regulatory Pathway

Document Requirements

Health Canada Timelines

Low

I

NA

MDEL

  • MDEL application
  • QMS procedures

NA

Low-Moderate

II

MDSAP certificate

MDL

  • MDL application
  • Fee form
  • Labeling documents
  • Declaration of Conformity (Doc)
  • MDSAP certificate

15 Days

High-Moderate

III

MDSAP certificate

MDL

  • MDL application
  • Declaration of Conformity (Doc)
  • ISO 13485:2016 certificate with MDSAP certificate
  • Labeling
  • Technical files as per IMRDF

60 Days

High

IV

MDSAP certificate

MDL

  • MDL application
  • Declaration of Conformity (Doc)
  • ISO 13485:2016 certificate with MDSAP certificate
  • Labeling
  • Technical files as per IMRDF

75 Days

Expertise

Freyr Expertise

  • Device Classification and grouping services
  • Pre-Submission meetings with Health Canada
  • MDSAP Certification 
  • Distributor Identification/Qualification of distributor for compliance with Health Canada requirements
  • Medical Device Establishment Licence (MDEL)
  • Medical Device Licence (MDL)
  • Post Approval Change Management
  • Labeling services