Canada Medical Device Registration & Regulatory Consulting | GRP

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Canada / MEDICAL DEVICES CONSULTING

REGULATORY STRATEGY

Devices are classified according to a risk-based system, as in most other markets a manufacturer’s regulatory requirements in Canada depend on its device’s classification.

Manufacturers of most medical devices sold in Canada must obtain licenses through the Therapeutic Products Directorate’s Medical Devices Bureau, and also be listed in the Medical Device Active License Listing (MDALL). Many lowest-risk devices (Class I devices) do not require such licensing, but the companies must register with the Health Products and Food Branch Inspectorate using Medical Device Establishment Licenses (MDEL).

Moderate- and high-risk devices must also meet ISO 13485 quality system requirements plus the Canadian specific additions to the ISO 13485 standard in order to be marketed in Canada.

Let Global Regulatory Partners assist you in evaluating the Canadian medical device regulatory framework as it applies to your device(s). We can provide you with accurate and actionable analysis through our Global Regulatory Overview Report service.

Our country report for Canada covers the following issues:
  • Health Canada Regulatory Background
  • Product Assessment based on Canadian Requirements
  • Device Classification based on Health Canada rules
  • Authorized Representation requirements for Canada
  • Medical Device Registration Requirements
  • Labeling Requirements
  • Costs and Timeframes
  • Regulatory Roadmap for Canada
  • Post-market Surveillance Requirements

PRODUCT REGISTRATION

If you are planning on selling medical devices or in vitro diagnostic devices (IVDs) in Canada, you will most likely need to register your product by securing a license. There are two types of licenses issued by Health Canada.

Health Canada Medical Device Establishment License (MDEL)

If you manufacture Class I medical devices or IVDs and plan on selling directly into Canada without a distributor, you must secure a Medical Device Establishment License (MDEL).

If you choose to sell through distributors in Canada, your distributor requires have an MDEL. Medical device distributors and importers must secure an MDEL regardless of device classifications.

Health Canada Medical Device License (MDL)

The Canadian Medical Device License (MDL) is required for companies selling Class II, III, or IV medical devices in Canada. The MDL is a product approval, while a MDEL is a permit for the company/distributor/importer itself.

Canada’s Medical Devices License (MDL) is comparable to the US FDA 510(k) process. The process of securing an MDL is usually faster for Class II devices, about the same for Class III devices and more complicated for Class IV devices.

When applying for a Canadian Medical Device License, you will also need to prove that you have a certified ISO 13485:2003 quality management system that also meets the specific requirements of the Canadian Medical Devices Regulations (CMDR).

  • Confirming your device classification in Canada.
  • Completing and filing the Canadian Medical Device License (MDL) or Medical Device Establishment License (MDEL) application on your behalf.
  • Developing, implementing or modifying your ISO 13485:2003 quality management system to meet Canadian requirements.
  • Providing onsite employee training on ISO 13485:2003 and Canadian Medical Devices Regulations (CMDR).
  • Determining the proper annual license fee payable to Health Canada.
  • Providing onsite auditing to confirm compliance with ISO 13485:2003 and CMDR.

Medical Device Classification in Canada

Medical devices are classified based on Health Canada’s risk-based classification system. Devices in Canada are classified as Class I, II, III and IV using a set of 16 rules found in Schedule 1, Part 1 of the Canadian Medical Devices Regulations (CMDR) SOR/98-282.  IVDs are also classified as Class I, II, III and IV using a set of 9 rules can be found in Schedule 1, Part 2 of the Canadian Medical Devices Regulations (CMDR) SOR/98-282.

Device Class Description Example
 Class I Devices  Lowest Risk  Culture Media
 Class II Devices  Low Risk  Contact Lenses
 Class III Devices  Moderate Risk  Implantable Coronary Stents
 Class IV Devices:  High Risk  Prosthetic Heart Valves

 Types of registrations based on medical device classification

Device Class Type of Registration
 Class I Devices  Medical Device Establishment License (MDEL)
 Class II, III and IV Devices  Medical Device License

Application Submission and Review Process by HEALTH CANADA

Class I devices:
Apply for Medical Device Establishment License (MDEL)Documents must be submitted in English or French

Submit MDEL application, prepare mandatory procedures and pay Health Canada fees.

Approved applications will be posted on the Health Canada website and your MDEL certificate will be emailed to you.

Class II, III and IV devices:

  1. Implement an ISO 13485:2003 compliant quality management system which includes the additional specific requirements of the CMDR. ISO 13485 certification, used to demonstrate compliance with European regulations, does not meet Canadian requirements. Updates to the existing procedures, or new procedures, must be implemented.
  2. Have ISO 13485 quality system (re)audited by a Registrar accredited by Health Canada under the Canadian Medical Devices Conformity Assessment System (CMDCAS). Several large European Notified Bodies also act as Registrars recognized by Health Canada. Your new ISO 13485 certificate will be issued upon successful completion of the audit.
  3. Prepare Canadian Medical Device License (MDL) application for your device. Compared to a US 510(k) application, MDL applications are simpler for Class II devices and about the same for Class III devices. Class IV MDL applications are comparable to a US PMA application. Note that an MDL application is for the device itself whereas an MDEL is a permit for the distributor/importer, or a manufacturer of Class I devices. Documents must be submitted in English or French.
  4. Submit MDL application, Fee Form, labeling (IFU), Declaration of Conformity and ISO 13485 (CMDCAS) certificate. Pay Health Canada fees.
    For Class III and Class IV devices there are additional documents such Fee Form, labeling (IFU) and Premarket Review Document following the STED format, which may include the requirement for clinical data. Clinical data collected outside Canada is generally accepted.
  5. Health Canada reviews MDL application (Class II, III and IV) and Premarket Review Document (Class III and IV only).
  6. Issued licenses will be posted on the Health Canada website, and copies of your MDL will be emailed to you. Note: For Class IV MDLs Health Canada will post a summary of their decision on their website.

Applications Review Timelines by HEALTH CANADA

 Device Class Approval Time
Class I Devices 2-4 months
Class II Devices 1-2 months
Class III Devices 4-5 months
Class IV Devices: 6-8 months
Application’s content
Device Class  Requirements
 Class I Devices  Medical Device Establishment Application (MDEL) Form
 Class II Devices  Medical Device License Application Form

  • Description of the Device
  • Device History
  • Device Identifier
  • List of Recognized Standards
  • Review Documents:
    • Labelling
    • Fees
Class III Devices  Medical Device License Application Form

  • Name of the device
  • Manufacturer Information
  • Quality Management System Certificate
  • Intended Use of Device
  • Device History
  • Device Identifier
  • Compatibility of Interdependent Devices
  • List of Recognized Standards
  • Review Documents
    • Executive Summary
    • Table of Contents
    • Device Background
    • SSED
    • Near Patient Diagnostic Device Testing Results (if applicable)
    • Labelling Material
  • Fees
 Class IV Devices: Medical Device License Application Form

  • Name of the device
  • Manufacturer Information
  • Quality Management System Certificate
  • Intended Use of Device
  • Device History
  • Device Identifier
  • Compatibility of Interdependent Devices
  • List of Recognized Standards
  • Review Documents
    • Executive Summary
    • Table of Contents
    • Device Background
    • Risk Assessment
    • Quality Plan
    • Device Specific Detailed Information
    • Safety and Effectiveness Studies
    • Required information for any biological material (if applicable)
    • Near Patient Diagnostic Device Testing Results (if applicable)
    • Labelling Material
  • Fees

QUALITY COMPLIANCE

Health Canada requires medical device manufacturers to use a quality system certificate as evidence of compliance to the appropriate regulatory quality system requirement. Health Canada will only accept quality system certificates that have been issued by special third party auditing organizations called Canadian Medical Devices Conformity Assessment System (CMDCAS) recognized registrars. The Medical Devices Regulations do not require importers or distributors of medical devices to have a registered quality system.

Moderate- and high-risk devices must also meet ISO 13485 quality system requirements plus the Canadian specific additions to the ISO 13485 standard in order to be marketed in Canada.

On March 1st, 2016, the International Organization for Standardization (ISO) published the revised version of ISO 13485 titled “ISO 13485 – Medical Devices – Quality management systems – Requirements for regulatory purposes”. This revised version will supersede ISO 13485:2003. This revised standard is referred to as ISO 13485:2016.

Manufacturers of class II, III, and IV medical devices holding licences or applying for new or amended licences must complete the transition to ISO 13485:2016 by March 1st, 2019.

QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES IN CANADA

Manufacturers of Class II, III and IV devices must submit to Health Canada an ISO 13485:2003 quality systems certificate with medical device license applications. This must be issued by a by a registrar recognized by the Standards Council of Canada according to the CMDCAS. The registrar conducts a third-party audit for compliance with the standard and CMDR and issues the certificate with requirements specific to the CMDCAS program. Registration to the standard is an ongoing process, and related expenses are borne by the manufacturer. Manufacturers of Class I, special access, custom made and investigational devices are exempt from this requirement.

LOCAL REPRESENTATION

Canada is one of the few countries with a well-developed regulatory system for drugs and medical devices where a local representative is not required to market a product within its borders. Foreign manufacturers can register and market their drugs and devices in Canada without a local representative, except in the case of devices containing wireless technology.

Clinical Trials

Pre-Market Review document for Class III and IV devices, may include the requirement of clinical data. Clinical data collected outside Canada is generally accepted by Health Canada.

Manufacturer’s or device sponsors of Class II, III and IV medical devices who wish to conduct investigational tests for medical devices in Canada must submit an application for Investigational Testing Authorization.

Requirements for Approval of Clinical Trial Initiation

An application for an investigational testing authorization of a Class II device must contain the following items presented in four distinct chapters titled: Introduction, Institutional Information, Protocol, and Labelling.

The application for an investigational testing authorization for a Class III or IV medical device must contain the following information in six distinct chapters: Introduction; Risk Analysis; Institutional Information, Protocol, Labelling, and Investigator Agreements.

The following is the suggested content for an investigational testing application, some of the sections are not applicable to Class II applications.

  1. Executive Summary
  2. Background Information
    • 1 Device Description
    • 2 Design Philosophy
    • 3 Marketing History
  3. Risk Assessment
    • 1 Risk Analysis and Evaluation
    • 2 Previous Studies
    • 3 Alternate Treatments
    • 4 Precautions
  4. Institutional Information
    • 1 Investigator(s)
    • 2 Name of Institution(s)
    • 3 Research Ethics Board Approval(s)
  5. Protocol
  6. Device Label
  7. Investigator Agreement(s)

Following the review of the application, the Minister may issue an authorization to conduct the proposed investigational testing.

Canada medical device registration process

As per the Medical Devices Division of Health Canada, the target review time for a Class II, III, and IV medical device ITA is a total of 30 calendar days. First, the application will go through a screening process, and if it is accepted for review, a screening acceptance letter will be issued.

After approval of an ITA, a “No Objection Letter” (NOL) is sent to the Sponsor indicating Health Canada’s agreement on conducting the study. However, Health Canada requires notification of ethics clearance for the study through a Research Ethics Board prior to issuing a No Objection letter.

Requirements for conducting clinical trials

All investigational testing carried out in Canada must conform to the principles of the Declaration of Helsinki and the Medical Research Council’s “Code of Ethical Conduct for Research Involving Humans – May 1997.

Clinical trials involving medical devices should be compliant with ISO14155-2011 “Clinical investigation of medical devices for human subjects-Good clinical practice, which is harmonized with ICH-GCP guidelines for medical device trials.